Regulations on measurement units and measurement


Date FOR-2007-12-20-1723


Ministry of Industry and Ministry of Fisheries


Published in 2008 Booklet 1


Commencement 01/01/2008

Edited

FOR 2016-08-10-981 from 01/09/2016

Changes

FOR 1977-06-10-1, FOR-1994-12-23-4120, TO-1999-08-24-964, FOR-2001-12-05-1339, FOR 1995-06-08 -550, TO-1995-06-08-551, TO-1995-06-08-552, FOR-1996-11-25-1173, TO-2006-04-26-454, FOR 2006-04-26 -455, TO-2006-04-26-466, TO-2006-04-26-467, TO-2006-04-26-468, TO-2006-04-26-469, FOR 2006-04-26 -470, TO-2006-04-26-481, TO-2006-04-26-482, TO-2006-04-26-497, TO-2006-04-26-498, FOR 2006-04-26 -499, TO-2006-04-26-500, TO-2006-03-24-368

For
Norway

Legal

LOV-2007-01-26-4-§4, LAW-2007-01-26-4-§7, LAW-2007-01-26-4-§8, LAW-2007-01-26- 4 Section 10, LAW-2007-01-26-4-§17, LAW-2007-01-26-4-§18, LAW-2007-01-26-4-§19, LAW-2007-01- 26-4-Section 24, LAW-2007-01-26-4-§30, LAW-2007-01-26-4-§31, LAW-2007-01-26-4-§32, LAW-2007- 01-26-4-§35, LOV-1994-06-16-20-§7

Promulgated
11.01.2008 kl. 15.40


Corrected 26.05.2011 (EEA reference field)

Short Title
Regulations on measurement units and measurement

Chapter Overview:

Chapter 1 - Introductory provisions (§§ 1-1 - 1-2)
Chapter 2 - Units (§§ 2-1 - 2-10)
Chapter 3 - Measuring Tools, measurement methods and purposes that it requirements to (§§ 3-1 - 3-6)
Chapter 4 - requirements on the sale of measuring instruments (§§ 4-1 - 4-34)
Chapter 5 - requirements for measurement and measuring instruments in use ( §§ 5-1 - 5-10)
Chapter 6 - fees and charges (§§ 6-1 - 6-11)
Chapter 7 - Rules relating to the assessment and procedural administrative fines (§§ 7-1 - 7-3)
Chapter 8 - Final provisions (§§ 8-1 - 8-2)
Appendix no. 1 to regulations on measurement units and measurement, cf. regulations § 4-6.
Appendix no. 2 to Regulations on measurement units and measurement, cf. Regulations § 4-11.

Adopted of Trade and Industry (now Ministry of Industry and Ministry of Fisheries) on 20 December 2007 pursuant to the Act on 26 January 2007 no. 4 to units of measurement, measurement and standard time § 4, § 7, § 8, § 10 , § 17, § 18, § 19, § 24, § 30, § 31, § 32 and § 35 and Act of 16 June 1994. 20 concerning notified bodies whose task to conduct compliance assessments § 7.
EEA -henvisninger EEA agreement, Annex II, Sec. IX. 27 (Directive 2009/23 / EC), no. 24 (Directive 80/181 / EEC as amended by Directive 1999/103 / EC and Directive 2009/3 / EC) and no. 27b (Directive 2004/22 / EC), Annex II, Chapter. XIX (decision no. 768/2008 / EC) and Sec. IX (Directive 2014/32 / EC and Directive 2014/31 / EU).
Changes: Amended by Regulations 16 Dec 2008 no. 1399, September 30, 2009 no. 1225, 22 Dec 2009 No.. 1811, 15 Dec 2010 No.. 1741, 24 January 2012 No.. 91, November 16, 2012 No.. 1232, 5 Dec 2013 no. 1416, 12 Dec 2013 No.. 1554, 11 april 2014 No.. 565, 2 Dec 2014 no. 1515, 18 Dec 2015 No.. 1749, 17 Dec 2015 No.. 1887 29 January 2016 no. 124, 25 april 2016 No.. 427, 10 August 2016 No.. 981.
Corrections: 16.05.2008 (table 4, 6, 8), 26/05/2011 (EEA reference field).

Chapter 1 - Introductory provisions

§ 1-1. Scope This regulation contains supplementary provisions to the law on 26 January 2007 no. 4 to units of measurement, measurement and standard time. The regulation stipulates the cases in which there are requirements for measuring instruments and measurements. The regulation also establishes requirements for measuring instruments and rules on measurement units, fees and fines.

§ 1-2. Definitions In these regulations

A)

Authorized representative: any natural or legal person established in the Community who has received a written mandate from a manufacturer to act on his behalf in connection with specific tasks

B)

User: a natural or legal person who owns or disposes of measuring instrument and who are otherwise responsible for the measurement is made. Further clarification of who the user can be made in the instrument-specific regulations

C)

CE marking, marking the manufacturer indicates that the measuring instrument complies with all applicable requirements of the harmonized regulations that must be met to apply the mark

D)

Distributor means any natural or legal person who makes a measuring instrument available on the market, with the exception of the manufacturer or importer

E)

Initial approval: Decision declaring the relevant measure tool sold complies with the requirements set out in Chapter 4 Section 5 on national conformity assessment

F)

First time make available on the market: the first time the relevant measurement tool made available on the EEA market

G)

Make available on the market: any disclosure of a measuring tool as part of business for distribution or use on the EEA market regardless of whether the provision of compensation

H)


Harmonized standard: harmonized standard as defined in Regulation (EU) No. 1025/2012 Article 2. 1 c

I)

Importer means any natural or legal person established within the Community, who first makes a measuring instrument from a third country available on the EEA market

J)

Instrument specific regulation: regulation that provides technical requirements and other requirements to one or more specific types of measuring instruments or measurement methods

K)

Control, when associated with an audit examined whether a measuring tool when used meets the requirements of the dispenser

L)

Normative document: document containing technical specifications adopted by the International Organization for Legal Metrology (OIML)

M)

Monitoring control: a control of a measuring tool implemented as a result of a message from a user or others, and that will determine if the measuring tool when used in accordance with the requirements of the dispenser

N)

Annual inspection: an inspection of a measuring instrument which determines whether the measuring tool when used in accordance with the requirements of the dispenser

O)

Producer: any natural or legal person who manufactures measuring instrument or receiving a measuring instrument designed or manufactured, and that either promote this measure instrument under his name or trademark, or using it for their own purposes

P)

Conformity Assessment: the process that detects whether a measuring instrument meets the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time

Q)

Notified body: body that performs conformity assessment activities, and designated to undertake conformity assessment under the provisions of this regulation and in accordance with the Act of 16 June 1994. 20 concerning notified bodies

R)

Approval: Decision declaring a type of measuring instrument is in compliance with the requirements set out in Chapter 4 Section 5 of national conformity assessment.

Chapter 2 - Units

§ 2-1. Use The units are not allowed to use other units of measurement than the current measurement units as specified in the regulation unless exceptions are made in this chapter. Current units are established in accordance with the international system of measuring units (SI system). The definitions of the SI units are consistent with the definitions laid down by the General Conference on Weights and Measures (CGPM). In addition to the SI units applies to certain units of measurement that is defined independently of the SI system.
It is still allowed to use other devices within shipping, aviation and rail traffic if such devices are provided for in international conventions or agreements that Norway is obliged to follow.

§ 2-2. Additional Indications in non-current devices One size (result) may be entered in other units than those applicable under § 2-1, first paragraph if the tax return is in addition to an indication of the size of the current devices. Measuring Tools specified in § 3-1 may still not show sizes in other measurement units than the current unless Metrology has decided otherwise in the instrument-specific regulations.
Directions given in the current measurement units should be emphasized. Written or printed additional indications in other units must not be larger font size than the written prescription in the current measurement units.

§ 2-3. SI base units The following SI base units apply:
Table 1. SI base units

Size
Basic unit

Name
Symbol

Length
meters
m

Mass
kilogram
kg

Time
second
p

Electrical power
amps
A

Thermodynamic temperature kelvin

K

Substance Amount
mole
mole


Brightness candela
cd

§ 2-4. Definitions of SI base units SI base units have the following definitions:

A)

Unit of length A meter is the length of the stretch that light in empty space during 1/299 792 458 seconds

B)

Unit of mass: A kilogram is the mass of the international kilogram prototype

C)

Unit time: One minute is 9,192,631,770 periods of the radiation corresponding to the transition between the two hyperfinnivåene in the ground state of the cesium 133 atom

D)

Unit of electric current: An ampere is the constant electric current produces a mutually power of 0.2 micro newtons per. meter head when the power goes through each of the two rectilinear parallel, infinitely long conductors with circular and negligibly small cross-section, and leaders are placed in one meter spacing in empty space

E)


Unit of thermodynamic temperature: A kelvin is the fraction 1 / 273.16 of the thermodynamic temperature of the water triple point. The unit kelvin and its symbol K is also used to express a temperature range or a temperature difference. Thermodynamic temperature (T) are in addition to expressed in kelvins also expressed in Celsius temperature:

Table 2. Name and symbol of Celsius temperature

Size
Unit

Name
Symbol

Celsius temperature
Degree Celsius
° C

Celsius temperature (t) is defined by the following equation: t = T - 273.15 K.
unit degree celsius is equal unit kelvin, and a temperature range or a temperature difference can also be expressed in degree celsius

F)

Unit of amount of substance: A mole is the amount of substance in a system that contains as many elementary entities as there are atoms in 0.012 kg of carbon 12. When the device moles used, must elemental units specified. These may include atoms, molecules, ions, electrons, other particles or specified groups of such particles

G)

Device brightness: A candela is brightness in a given direction from a source that emits monochromatic radiation of frequency 540 x 1012 herz and a radiant power in the given direction of 1/683 watts per. steradian.

§ 2-5. Derived SI units Derived SI units are coherent (coherent) combinations of the SI base units and / or supplement units in SI and is formed by algebraic multiplication or division thereof. These include:
Table 3. Examples of derived SI units expressed by the basic units and supplement devices

Size
SI unit

Name
Symbol

Area
square
m²

Volume
cubic
m³

Speed ​​
meters pr. second
m / s


Acceleration meter per. second squared
m / s2

Angular speed
radian per. second
rad / s


Density kilogram per. cubic
kg / m³


Kinematic viscosity meter in another pr. second
m² / s

Mass Concentration
kilograms per. cubic
kg / m³

Concentration
moles. cubic
mol / m³


Luminance candela per. square
cd / m²

The following derived SI units have their own names and symbols:
Table 4. Derived SI units having its own name and symbol

Size
SI unit
Expressed in

Name
Symbol
Derived units
Basic Devices and supplement called

Plan angle
radian
row

M · m-1


Spatial angle steradian sr


M² · m⁻²
Frequency
hertz
Hz

S-1


Power newton
N

M · kg · s-2

Press, excitement
pascal
Pa
N / m
m⁻¹ · kg · s-2

Energy, work, heat
joules
J
N · m
m² · kg · s-2

Power
watts
W
J / s
m² · kg · s-3

Electric charge, quantity of electricity coulomb

C

A · ​​s

Electric potential, voltage, potensialdifferens, electromotive force volt


V J / C = W / A
ms · kg · s⁻³ · A-1


Capacitance farad
F
C / V
m⁻² · kg⁻¹ · s4 · A2

Resistance
ohm
Ω
V / A = 1 / S
m² · kg · s⁻³ · A-2


Conductance siemens
S
A / V = ​​1 / Ohm
m⁻² · kg⁻¹ · s³ · A2


Magnetic flux weber Wb

V · s
m² · kg · s⁻² · A-1

Magnetic flux density, magnetic induction
tesla
T
Wb / m²
kg · s⁻² · A-1


Inductance henry
H
V · s / A = Wb / A
m² · kg · s⁻² · A-2

Luminous flux, luminous flux
lumen
ch

Cd · sr


Illuminans Lux
lx
lm / m²
m⁻² · cd · sr

Activity for a radionuclide becquerel


Bq
S-1

Absorbed dose, specific energy (awarded), Kerma
gray
Gy
J / kg
m² · s-2

Dose equivalent, environmental dose equivalent, directional dose equivalent, dose equivalent person
sievert
A
J / kg
m² · s-2

Catalytic activity
Katal
Kat

S⁻¹ · mol

The derived SI units radian and steradian is defined as follows:

A)

Unit angle: A rad is the angle between two radii defining an arc of circumference with a length equal to the radius

B)

Unit solid angle a steradian is the solid angle as the vertex of a bullet will center defining an area of ​​the ball surface which is equal to a square with side edges similar bullet radius.

The derived SI units may again be used to express other derived units in a simpler way than the basic units. These include:
Table 5. Examples of derived SI units which may be expressed by combinations of base units and units with own name

Size
SI unit

Name
Symbol
Expressed in base units


Dynamic viscosity pascal second
Pa
m⁻¹ · kg · s-1

Tightening torque
meters newton
mN
m² · kg · s-2

Heat capacity
joules per. kelvin
J / K

M² · kg · s⁻² · K-1

Specific heat capacity
joules per. kilogram kelvin
J / (kg.K)
m² · s⁻² · K-1

Electric field strength
volts per. meters
V / m
m · kg · s⁻³ · A1


Permittivity farad per. meters
F / m
m⁻³ · kg⁻¹ · s4 · A-2

Molar entropy
joules per. mole kelvin
J / (mol. K)
m² · kg · s⁻² · K⁻¹ · mol-1

§ 2-6. Decimal multiples of SI units (prefixes) The following prefixes are used to form the names and symbols of decimal multiples of SI units:
Table 6. Prefixes in SI

Factors units multiplied by
Prefix

Name
Symbol

1024

Yotta
Y

1021


Zetta Z

1018


Exa E

1015


Peta P

1012

Tera
T

109

Giga
G

106

Mega
M

1000
kilograms
k

100
pound
h

10
decadence
when


0.1 deci
d

0.01
centi
c

0001
milli
m

10-6

Micro
μ

10-9

Nano
n

10-12

Piko
p

10-15

Femto
f

10-18

Atto
a

10-21

Zepto
z

10-24

Yokto
y

Compound prefixes, i.e. prefixes formed by several of the above code is put together, shall not be used.
Name and Symbol for multiples of the basic unit of mass is formed by adding prefixes to the name gram (g), such as milligrams (mg).

§ 2-7. Special names of certain decimal multiples of SI units following decimal multiples have special names:
Table 7. Special names of decimal multiples of SI units

Size
Unit

Name
Symbol
Expressed in SI units

Volume
l
l or L
1 l = 1 dm³ = 0.001 m³

Mass
tons
t
1 t = 1 Mg = 1000 kg


Acreage ar
a
1 a = 100 m²

SI prefixes can be used with units in Table 7.
100 ar = 10,000 m², called hectares (ha). 10 years = 1000 m², called hectares (ha).

§ 2-8. Units are defined by SI units but are not decimal multiples following devices are defined by the SI units but are not decimal multiples:
Table 8. Entities defined from SI units, but as not decimal multiples

Size
Unit

Name
Symbol
Expressed in SI units

Time
minute
my
1 min = 60 s


Hour h
1 h = 60 min = 3600 s

Days
d
1 d = 24 h = 86 400 s


Angle degree
you
1 you = π / 180 consecutive


Minutes '1' = 1 deg / 60 = π / 10800 row


Second "1" = 1 '/ 60 = π / 648000 row

Gon (nygrad)

gon 1 gon = π / 200 consecutive

§ 2-9. Entities defined independently of the SI units units in Table 9 are only allowed to be used temporarily and only for special purposes. The devices can not be used in combination with SI units.
Table 9. Entities defined independently of the SI units

Size
name
Value


Energy electron volts (eV)
1 eV approximately equal to 0.16021773 .alpha

Length
nautical mil
1 nautical mil = 1852 m

Press
bar
1 bar = 100 000 Pa

Speed ​​
knots
1 knot = 1 nautical mil per. hour

Blood Pressure
mmHg
1 mmHg = 133.322 Pa

Mass of stones
carat
1 carat = 200 mg

The units nautical mil and knots allowed only used until further notice in maritime and air transport, especially for navigation.
SI prefixes can be used with the device electron volts (eV).

§ 2-10. Use of device symbols in signage and printing In pressurized unit symbols with straight (vertical) font regardless of which font is used in the remaining text. Unit symbols are printed without majority mission and without trailing period. The value of a size printed with distance between targets and unity.
Name and symbols for units are printed in lowercase, but the device is based on a person's name is written the first letter of the symbol in uppercase. The symbol for the unit for volume (liter) can still written in uppercase.
When a derived unit is the quotient between devices and this will be printed in a computer system with limited range of characters, the quotient is indicated by separating the numerator and denominator with a forward slash (/), or by entering the denominator with negative exponent, eg. m / s or ms⁻¹ of meters per second.
A prefix is ​​written without spaces in front of a unit symbol. The prefix is ​​chosen such that it gives practical values ​​of the measures. It is customary to select the prefix provides targets between 0.1 and 1 000

Chapter 3 - Measuring Tools, measurement methods and purposes that the requirements are

§ 3-1. Measuring Tools subject to requirements when sold or offered for sale following measuring instruments are subject to requirements when sold or offered for sale:

A)
Automatic scales

B)
Waste Indicators

C)

A meter measuring active energy or a combination of active and reactive energy

D)
Bottles used as measuring containers

E)
Multi Dimensional Surveyors

F)
measuring system for continuous and dynamic measurement of liquids other than water

G)
Non-automatic weighing instruments

H)
Length Measuring Instruments

I)
Length measurements measuring level in tanks used as the basis for calculating the financial settlement, cf. § 3-4 second paragraph

J)
Material measurements to be used as the basis for calculating the financial settlement, cf. § 3-4 second paragraph

K)
aim Anker used to set the volume using either fixed mark, by bearing or otherwise and to be used as a basis for calculating the financial settlement, cf. § 3-4 second paragraph || |
L)
Opphenganordninger (slaughter hooks)

M)
taximeters

N)

Counters
O)
Heat meters.

§ 3-2. Other forms of transfer of measuring instruments Metrology may by regulation or individual decision lay down that it should also apply to requirements for measuring instruments that are transferred otherwise than by sale.

§ 3-3. Exemptions from requirements for sales Metrology may issue regulations that measuring instruments specified in § 3-1 is nevertheless not to be subject to further requirements on the sale.

§ 3-4. Measuring Tools and measurements subject to requirements using the financial settlement requirements are laid down using the following measuring instruments when the measurement result is used as the basis for calculating the financial settlement:

A)
Automatic discontinuous summation weights, cf. Regulation 21 December 2007 no. 1737 on requirements for automatic discontinuous summation weights

B)
Automatic gravimetric filling machines, cf. Regulation 21 December 2007 no. 1747 on requirements for automatic gravimetric filling machines

C)
Automatic train weights, cf. Regulation 21 December 2007 no. 1741 on requirements for automatic train weights

D)
Instruments for automatic weighing of individual quantities (catch weight), cf. Regulation 21 December 2007 no. 1742 on requirements for instruments for automatic weighing of individual quantities (catch weights)

E)
Belt weighers, cf. Regulation 21 December 2007 no. 1736 on requirements for conveyor scales

F)
A meter measuring active energy or a combination of active and reactive energy in a lavspenningsdistribusjonsnett, ref. Regulation of 28 December 2007. 1753 on requirements for electricity meters

G)
Bottles used as measuring containers, cf. Regulation 21 December 2007 no. 1732 on requirements for bottles used as measuring containers (measuring bottles)

H)
Multi Dimensional Indicators, cf. Regulation 21 December 2007 no. 1746 on requirements for instruments to multidimensional measurements (multi-dimensional gauges)

I)
measuring system for continuous and dynamic measurement of liquids other than water, cf. Regulation 21 December 2007 no. 1738 relating to requirements for measuring systems for continuous and dynamic measurement of liquids other than water

J)
Non-automatic weighing instruments, cf. Regulation 21 December 2007 no. 1735 on requirements for non-automatic weighing instruments

K)
Length Measuring Instruments, cf. Regulation 21 December 2007 no. 1740 on requirements for length measurement instruments

L)
Length measurements that measure levels in tanks

M)
Material measurements, cf. Regulation 21 December 2007 no. 1739 on requirements for material measurements

N)
aim Anchor, cf. Regulation 21 December 2007 no. 1748 on requirements for calibration of the target anchor used for calculations of financial settlement.

O)
taximeters, cf. Regulation 1 October 2009 No.. 1226 on requirements for taximeters.

A measuring instrument used for financial settlement when a test result forms the basis for calculating the monetary value (price) to be paid or settled by other means, including the calculation of values ​​at commercial transactions and direct sales to the public, determining the content of packaged goods, tax, customs, tax, premium, bonus, piecework, fines, fees, remuneration, compensation or payment of a similar nature.
If in the production of a finished package used to instruments not subject to claims or does not meet the requirements of the dispenser, the contents of the finished package is checked with a suitable measuring instrument is subject to requirements and meets. Metrology can in each case to accept sample based self-monitoring.

§ 3-5. Measuring Tools subject to requirements using for purposes other than financial settlement requirements are laid down by the use of non-automatic weighing instruments used for

A)
determining mass with respect to the application of a law, regulation or by expert opinions in connection with litigation

B)
producing prescription medicines in pharmacies

C)
determine mass in analyzes carried out in medical and pharmaceutical laboratories.


Requirements are laid down using personal scales used to determine mass in medical practice by weighing of patients with the aim of monitoring, diagnosis and medical treatment.

§ 3-6. Metrology permitted to adopt clarifications and exceptions during use metrology may by regulations or individual specific regulations concerning when a measuring instrument is deemed to be used for a specified uses.
Metrology may issue regulations that measuring instruments specified in § 3-4 is nevertheless not to be subject to further requirements during use.

Chapter 4 - Requirements on the sale of measuring instruments

Section 1 - Requirements for all measuring tools from the sale

§ 4-1. Requirements for measuring instruments made available on the market measuring items that are made available on the market shall meet the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time. The manufacturer may choose any technical solution that meets the requirements.

§ 4-2. Requirements for conformity assessment Measuring Tools mentioned in § 3-1 shall satisfy the requirements of national conformity assessment in paragraphs 1 and 5. This does not apply following measuring instruments that satisfy the requirements for conformity assessment under the EEA Agreement in paragraphs 1 and 2:

A)
Automatic discontinuous summation weights, cf. Regulation 21 December 2007 no. 1737 on requirements for automatic discontinuous summation weights

B)
Automatic gravimetric filling machines, cf. Regulation 21 December 2007 no. 1747 on requirements for automatic gravimetric filling machines

C)
Automatic train weights, cf. Regulation 21 December 2007 no. 1741 on requirements for automatic train weights

D)
Waste Indicators, cf. Regulation 21 December 2007 no. 1744 on requirements for exhaust gas gauges

E)
A meter for use in residential, commercial or light industrial, ref. Regulation for electricity meters

F)
Multi Dimensional Indicators, cf. Regulation 21 December 2007 no. 1746 on requirements for instruments to multidimensional measurements

G)
measuring system for continuous and dynamic measurement of liquids other than water, cf. Regulation 21 December 2007 no. 1738 relating to requirements for measuring systems for continuous and dynamic measurement of liquids other than water

H)
Non-automatic weighing instruments, cf. Regulation 21 December 2007 no. 1735 on requirements for non-automatic weighing instruments

I)
Instruments for automatic weighing of individual quantities (catch weights), cf. Regulation 21 December 2007 no. 1742 on requirements for catch weights

J)
Length Measuring Instruments, cf. Regulation 21 December 2007 no. 1740 on requirements for length measurement instruments

K)
Material measurements, cf. Regulation 21 December 2007 no. 1739 on requirements for material measurements

L)
taximeters, cf. Regulation 1 October 2009 No.. 1226 on requirements for taximeters

M)
Belt weighers, cf. Regulation 21 December 2007 no. 1736 on requirements for conveyor scales

N)
Counters for use in residential, commercial or light industrial, cf. Regulation 21 December 2007 no. 1745 on requirements for water meters

O)
Heat meters for use in residential, commercial or light industrial, cf. Regulation 21 December 2007 no. 1743 on requirements for heat meters.

Measuring Tools under subsection already sold in the EEA before 30 October 2006, shall by reselling still follow the requirements of national conformity assessment in paragraphs 1 and 5.

§ 4-3. Exemptions from requirements for conformity assessment Measuring equipment will be shown at fairs, exhibitions, demonstrations and the like without the conformity assessment is carried out if clear labeling clearly indicates that the measuring instrument is not in accordance with established requirements and can not be made available on the market or put into service before it is brought in accordance with the requirements applicable to the respective measurement tool. This subsection does not apply to non-automatic weighing instruments.
Metrology may apply in individual cases decide that a measuring instrument covered by § 3-1 shall be exempt from the requirements under this chapter and instrument-specific regulations before it is sold. Such exceptions may be granted only if there will be requirements for measuring instrument when it is in use and otherwise justifiable. Metrology may impose conditions for the exception.

§ 4-4. Conformity Marking Measuring Tools where decided conforming, conformity marked with the CE marking and associated metrological label as defined in § 4-9. It is not allowed to affix conformity markings if the requirements of the dispenser is not met.

§ 4-5. Information that must accompany the measuring instrument Information about permissible error limits (tolerances), maximum and minimum load using and what requirements the measuring tool in general should satisfy, shall follow the measuring tool with policy compliance.

Information necessary to ensure proper use of the measuring instrument shall be in Norwegian. Metrology may in individual cases permit that the information is in Swedish, Danish or English.

Section 2 - Requirements for conformity assessment under the EEA Agreement

§ 4-6. Conformity assessment procedures under the EEA Agreement conformity assessment for the individual measuring instruments are permitted only performed after the procedures in the modules as shown in Table 10. The contents of the modules are set out in Annex 1 to the Regulations. The manufacturer can choose which of the following conformity assessment procedures to be used:
Table 10. Procedures for conformity assessment

Measuring Tools
Description conformity assessment procedure
Modules

Water meters, heat meters, electricity meters, exhaust gas meters and taximeters
EU type approval and initial verification
EC type examination and according to type based on quality assurance
production process.
Conformity based on full quality assurance and
design examination
B + F

B + D

H1

Measuring system for continuous and dynamic measurement of liquids other than water
EU type approval and initial verification
EC type examination and according to type based on quality assurance
manufacturing process
Conformity based on full quality assurance
and construction survey
Conformity based on unit verification
B + F
B + D

H1

G

Material meteyard
Conformity based on product verification
Quality assurance of the production process
EC type examination and according to type based on quality assurance
manufacturing process
Conformity based on full quality assurance
Conformity based on unit verification
F1
D1
B + D

H
G

Mechanical systems:
Belt weighers, automatic discontinuous container scales, railroad scales, catch weights and automatic gravimetric filling machines
EU type approval and compliance with type based on
quality assurance of the production process
EC type examination and according to type based on
quality assurance of final product
EU type approval and initial verification
Quality assurance of the production process
Conformity based on product verification
Conformity based on unit verification
Conformity based on full quality assurance
and construction survey
B + D

B + E

B + F
D1
F1
G
H1

Electromechanical instruments:
Belt weighers, automatic discontinuous container scales, railroad scales, catch weights and automatic gravimetric filling machines
EU type approval and compliance with type based on
quality assurance of the production process
EC type examination and according to type based on
quality assurance of final product
EU type approval and initial verification
Conformity based on unit verification
Conformity based on full quality assurance
and construction survey
B + D

B + E

B + F
G
H1

Electronic systems or systems with software:
Belt weighers, automatic discontinuous container scales, railroad scales, catch weights and automatic gravimetric filling machines
EU type approval and compliance with type based on
quality assurance of the production process
EU type approval and initial verification
Conformity based on unit verification
Conformity based on full quality assurance
and construction survey
B + D

B + F
G
H1

Mechanical or electromechanical instruments:
Length Measuring Instruments and multi-dimensional gauges
Conformity based on product verification
Quality assurance by inspection and testing of the final product
Quality assurance of the production process
EU type approval and initial verification
EC type examination and according to type based on
quality assurance of final product
EC type examination and according to type based on
quality assurance of the production process
Conformity based on full quality assurance
Conformity based on full quality assurance
and construction survey
Conformity based on unit verification
F1
E1
D1
B + F
B + E

B + D

H
H1

G

Electronic instruments or instruments containing software:
Length Measuring Instruments and multi-dimensional gauges
EU type approval and initial verification
EC type examination and according to type based on
quality assurance of the production process
Conformity based on full quality assurance and design examination
Conformity based on unit verification
B + F
B + D

H1

G


Non-automatic weighing instruments with electronic means and means for measuring the load that does not use feathers to bring the load in equilibrium
EU type approval and initial verification
EC type examination and according to type based on
quality assurance of the production process
Conformity based on unit verification
B + F
B + D

G

Non-automatic weighing instruments without electronic means and means for measuring the load that does not use feathers to bring the load in equilibrium
EU type approval and initial verification
EC type examination and according to type based on
quality assurance of the production process
Conformity based on quality assurance of the production process
Conformity based on product verification
Conformity based on unit verification
B + F
B + D

D1
F1
G

§ 4-7. Requirements for conformity assessment under the EEA Agreement The requirements laid down in the instrument-specific regulations is considered fulfilled when the measuring equipment is in compliance with

1.
Harmonized standards or parts thereof which have been published referring to the Official Journal, or

2.
Those parts of a normative document that is published in a list in the Official Journal.

If a measuring instrument only partially in accordance with harmonized standards or normative documents mentioned in the first paragraph, it shall be presumed compliance with the essential requirements corresponding to the elements of the standard or the normative document, which measure the tool matches.

§ 4-8. Effect of valid conformity assessment under the EEA Agreement Measuring Tools which satisfy the requirements laid down in or pursuant to the units of measurement, measurement and standard time, shall not be impeded made available on the market and / or adopted by reference to matters regulated by or pursuant of the law on measurement units, measurement and standard time.
It is not allowed to do measuring instruments that do not meet the requirements of this regulation and the instrument-specific regulations available on the market, whether the measuring instrument otherwise meets the requirements of the relevant instrument-specific regulations.

§ 4-9. Labelling requirements for conformity assessments under the EEA Agreement CE marking and additional metrological marking shall be affixed before the measuring instrument first made available on the market. CE marking and additional metrological marking can be applied to measuring instrument during the manufacturing process if it is justified. The previous sentence does not apply to non-automatic weighing instruments. Conformity marking consisting of

A)
CE marking

B)
additional metrological marking

C)
identification number of the relevant notified body.

CE marking shall be in accordance with Regulation (EC). 765/2008 Article 30, as incorporated into the EEA care law. The general principles of Article 30 applies, mutatis mutandis, to the supplementary metrology marking.
The supplementary metrology marking consists of the letter "M" and the last two digits of the year of application, surrounded by a rectangle. Rectangle height should be equal to the height of the CE marking. The supplementary metrology marking shall immediately follow the CE marking.
The identification number of the relevant notified body, if the agency is involved in the production control phase as indicated in Annex 1, follow the CE marking and the supplementary metrology marking. The previous sentence does not apply to non-automatic weighing instruments. The identification number shall be applied by the notified body or by the manufacturer or his representative in accordance with instructions of the notified body.
If the measuring instrument consists of a number of components that work together, but that is not under the units, the CE marking and additional metrological marking applied to the meter's main component. This section does not apply to non-automatic weighing instruments.
CE marking and the supplementary metrology marking shall be affixed measuring instrument or måleredskapets nameplate and be visible, indelible and lasting. If it is not possible or desirable due måleredskapets art to affix the CE marking and additional metrological marking, the markings applied to any packaging and accompanying documents. The affected notified body's identification number shall be indelible or self-destructive upon removal. The previous sentence does not apply to non-automatic weighing instruments.

§ 4-10. Conformity assessment under the EEA Agreement Conformity assessment shall be carried out by a Notified Body. The manufacturer can freely choose between notified bodies designated to carry out conformity assessments for the type of measuring instrument.

§ 4-11. Requirements for EC Declaration
1.
EU declaration of conformity shall state that the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time are proven true.


2.
EC declaration of conformity shall have the structure as defined in Appendix 2, contain the elements specified in the relevant modules set out in Annex 1 and continuously updated. EC declaration of conformity must be translated into Norwegian, Swedish, Danish or English.

3.
If a measuring instrument covered by more than one piece of legislation where the EU declaration of conformity is required, shall be prepared only one EU declaration of conformity for all such acts. EU declaration of conformity shall identify the relevant acts and where they are published.

4.
By preparing EC declaration of conformity, the manufacturer assumes responsibility for the measuring instrument meets the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time when it first made available on the EEA market.

§ 4-12. Technical documentation in conformity assessment procedures under the EEA Agreement for conformity assessment to be undertaken by the notified body, the manufacturer shall submit technical documentation where appropriate.
The technical documentation must clearly describe måleredskapets design, production and operation, and should make it possible to assess whether the measurement tool is in accordance with the relevant requirements set out in the instrument-specific regulations.
The technical documentation shall be sufficiently detailed to ensure the following:

A)
definition of metrological characteristics

B)
that the manufactured measuring instrument the measurement performance can be reproduced when properly adjusted by appropriate aids

C)
måleredskapets integrity (eg. Documentation type sealing and identification of software).

The technical documentation shall, insofar as is relevant for assessment and identification of the type or measuring instruments, include the following:

A)
a general description of the measuring instrument

B)
overall design and manufacturing drawings and plans of components, sub-assemblies, circuits, etc.

C)
production that ensures uniform production

D)
optional description of the electronic devices with drawings, diagrams, flowcharts with logic and general information about the software, explaining the characteristics and behavior

E)
descriptions and explanations necessary to understand the letter b), c) and d), including måleredskapets behavior

F)
a list of the standards and normative documents as mentioned in § 4-7, which wholly or partly used

G)
descriptions of solutions used to meet the basic requirements if the standards or normative documents referred to in § 4-7 have not been applied, including a list of other relevant technical specifications used

H)
results of design calculations, examinations, etc.

I)
EC type examination certificates or EU certificates for construction survey for measuring instruments containing parts identical to those used in the construction

J)
relevant test results, if necessary, to detect the type or measuring instruments in accordance with

1.
Requirements set out in the instrument-specific regulations under specified operating conditions and under specified environmental disturbances

2.
Durability specifications for gas meters, water meters, heat meters and metering system for continuous and dynamic measurement of liquids other than water.

It shall be assumed according to the relevant tests set forth in subparagraph j above if the corresponding tests are performed in accordance with the relevant documents mentioned in § 4-7 and if the test results ensure compliance with the basic requirements. This section does not apply to non-automatic weighing instruments.
The manufacturer shall specify where sealing and marks are placed. The manufacturer shall also specify the conditions for compatibility with interfaces and sub-assemblies, where relevant.
Documents and correspondence relating to conformity assessment shall be in Norwegian, English, Swedish, Danish or another language acceptable to the notified body.

§ 4-13. Measuring Tools meeting the requirements of Directive 2009/23 / EC and 2004/22 / EC Measuring Tools meeting the requirements of Directive 2009/23 / EC and Directive 2004/22 / EC and was first made available on the market before 20 April 2016, may still be made available on the market and / or put into service after that date.
Certificates issued pursuant to Directive 2009/23 / EC and Directive 2004/22 / EC are valid also after April 20, 2016.

Section 3 - Requirements for economic operators obligations in conformity assessment procedures under the EEA Agreement

§ 4-14. Manufacturer obligations
1. When the manufacturer first time doing their measuring instruments available on the market and / or puts them to use, he / she shall ensure that the measuring equipment is designed and manufactured in accordance with the requirements established pursuant to the Law on measurement units, measurement and standard time.


2. The manufacturer shall establish the technical documentation referred to in § 4-12. The manufacturer must perform or have performed the appropriate conformity assessment procedure, cf. § 4-6 Table 10.
When the manufacturer through conformity assessment procedure has been documented that the measuring instrument complies with the applicable requirements in or pursuant to the Law on measurement units, measurement and standard time, the manufacturer draw up an EU declaration of conformity and affix the CE marking and additional metrological marking.

3. The manufacturer shall keep the technical documentation and the EC declaration of conformity for 10 years after the measuring instrument was first made available on the market.

4. The manufacturer must ensure that there are procedures to ensure that series-produced measuring instruments are consistent with the requirements established pursuant to the Law on measurement units, measurement and standard time. Due account should be given to changes at måleredskapets structure or characteristics, changes in the harmonized standards, normative documents and other technical specifications referred to in order to document the measuring instrument meets the requirements.
When deemed appropriate with regard to måleredskapets performance, the manufacturer shall carry out random checks of measuring instruments made available on the market, investigate and, if necessary, keep a register of complaints, of measuring instruments that do not meet the requirements and of measuring instruments which are withdrawn . The manufacturer shall keep distributors informed of any such monitoring.

5. The manufacturer shall ensure that measuring instruments that he / she first made available on the market, suffered a type plate, batch or serial number, or another form of indication which makes it possible to identify the measuring instrument. If this is not possible because of måleredskapets size or nature, the information stated in a document attached measuring instrument and on any packaging, according to the provisions of Chapter 2 of the instrument-specific regulations on "information to be applied or follow (the current measuring tool). " The previous sentence does not apply to non-automatic weighing instruments.

6. The manufacturer must indicate on the measuring instrument;

A)
manufacturer's name,

B)
manufacturer registered trade name or registered trademark and

C)
address where the manufacturer can be contacted.

If this is not possible, the information stated in a document attached measuring instrument and on any packaging, according to the provisions of Chapter 2 of the instrument-specific regulations on "information to be applied or follow (the current measuring instrument)." The address shall indicate only one place where the manufacturer can be contacted. Contact information should be in a language easily understood by end-users and market surveillance authorities.

7. The manufacturer shall ensure that a copy of the EC declaration of conformity and instructions and information in accordance with the provisions of Chapter 2 of the instrument-specific regulations on "information to be applied or follow (the current measurement tool)" is attached when the measuring instrument the first time made available on the market. Information necessary to ensure proper use of the measuring instrument shall be in Norwegian. Metrology may in individual cases permit that the information is in Swedish, Danish or English. Instructions, information and labeling must be clear, obvious and understandable.
For non-automatic weighing instruments do not need EC Declaration lying by, and instructions and information need not be in accordance with the provisions of Chapter 2 of the instrument-specific regulations on "information to be applied or follow (the current measuring tool)» .

8. If a manufacturer considers or has reason to believe that a measuring instrument which he first made available on the market do not meet the requirements of or pursuant to the Law on measurement units, measurement and standard time, the manufacturer shall immediately implement the corrective measures necessary for the measuring instrument meets the requirements, and if necessary prohibit measuring instrument traded or withdraw it. If the measuring tool involves risks, the manufacturer shall also immediately inform the relevant national authorities of the country where he / she has made the measuring instrument available on the EEA market. It shall in particular provide information about the noncompliance and of any corrective measures taken.

9. Upon request from a relevant national authority, the manufacturer must cooperate with this on any action taken to reduce risk from the measuring instruments manufacturer has made available on the market first.

§ 4-15. Authorized representative obligations
1. The manufacturer may appoint an authorized representative by written authorization.

The following obligations shall not be covered by the authorized representative's mandate;

A)
requirements in § 4-14 paragraph 1

B)
obliged to draw up technical documentation, ref. § 4-14 paragraph 2.

2. Authorized representative shall perform the tasks specified in the mandate received from the manufacturer. The authorization shall at least allow the authorized representative to do the following:

A)
comply with § 4-14 paragraph 3 available to the national market surveillance authorities,

B)
upon request, to cooperate with the relevant national authorities about any measure taken to reduce the risk of the measuring instruments covered by the delegate authority.

§ 4-16. Importer's obligations
1. Importer should only be the first time make available on the market measuring instruments which meet the requirements of or pursuant to the Law on measurement units, measurement and standard time.

2. The importer shall, before he / she makes a measuring instrument the first time on the market and / or taking a measurement tool in use, make sure

A)
manufacturer has carried out the relevant conformity assessment procedure, cf. § 4-6 Table 10

B)
manufacturer has drawn up the technical documentation,

C)
measuring instrument bears the CE marking and the supplementary metrology marking,

D)
a copy of the EC declaration of conformity and the required documents are attached measuring instrument, and

E)
manufacturer has complied with the requirements of § 4-14 paragraph 5 and 6

If an importer considers or has reason to believe that a measuring instrument does not meet the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time, he / she shall not make the measuring instrument available on the market the first time or using it before it meets the requirements. If the measuring tool involves risk, the importer shall inform the manufacturer and the market surveillance authorities thereof.

3. The importer shall indicate on the measuring instrument;

A)
importer name,

B)
importer registered trade name or registered trademark and

C)
address where the importer can be contacted.

If this is not possible, the information stated in a document attached measuring instrument and on any packaging, according to the provisions of Chapter 2 of the instrument-specific regulations on "information to be applied or follow (the current measuring instrument)." Contact information should be in a language easily understood by end-users and market surveillance authorities.

4. The importer shall ensure that the measuring instrument is attached instructions and information in accordance with the provisions of Chapter 2 of the instrument-specific regulations on "information to be applied or follow (the current measuring instrument)." For non-automatic weighing instruments do not need instructions and information to comply with the provisions of Chapter 2 of the instrument-specific regulations on "information to be applied or follow (the current measuring instrument)." Instructions and information shall be in Norwegian. Metrology may in individual cases permit that the information is in Swedish, Danish or English.

5. Importer shall ensure that measuring instruments he / she is responsible for, stored and transported in such a way that måleredskapets accordance with the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time is not jeopardized.

6. § 4-14 paragraph 4 other sections also applies importer.

7. § 4-14 Section 8 also apply to the importer.

8. Importer shall keep the EU declaration of conformity for 10 years after the measuring instrument is made available on the EEA market the first time, available to the market surveillance authorities. Importer shall ensure that the technical documentation can be made available to the market surveillance authorities on request.

9. § 4-14 point 9 also applies importer.

§ 4-17. Distributor's obligations
1.
Distributor shall act with reasonable care with respect to the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time when making a measuring instrument available on the market and / or using it.

2.
Before the distributor makes a measuring instrument available on the EEA market and / or using it, he should verify that

A)
measuring instrument bears the CE marking and additional metrological marking,

B)
documents referred to in § 4-14 paragraph 7, first sentence, and the necessary documents are attached measuring instrument. Information necessary to ensure proper use of the measuring instrument shall be in Norwegian. Metrology may in individual cases permit that the information is in Swedish, Danish or English, and

C)
manufacturer and importer has complied respectively § 4-14 paragraph 5 and 6 and § 4-16 paragraph 3.


If a distributor considers or has reason to believe that a measuring instrument which he has made available on the EEA market does not meet the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time shall not measuring tool made available on the EEA market or put into service until it complies. If the measuring tool involves risks, Distributor further inform the manufacturer or importer as well as market surveillance authorities thereof.

3.
The distributor shall ensure that measuring instruments he is responsible for, stored and transported in such a way that måleredskapets accordance with the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time is not jeopardized.

4.
Distributor shall promptly provide to comply with § 4-14 Section 8 of the measuring tools he has made available on the market or put into use.

5.
§ 4-14 point 9 also applies to producers.

§ 4-18. Where the manufacturer's obligations apply to importer and distributor importer or distributor is considered as a manufacturer and is subject to the provisions applicable to that in § § 4-14 if this

A)
makes a measuring instrument available on the market the first time under its name or trademark or

B)
make changes on a measuring instrument that has already been made available on the market the first time, in such a way that it can affect måleredskapets accordance with the requirements laid down in or pursuant to the Law on measurement units, measurement and standard time || |
§ 4-19. Identification of economic operators Upon request, economic actors identify the following to market surveillance authorities;

A)
any economic operator who has received a measure coming from, and

B)
any economic operator that they have supplied a measuring instrument to

Economic operators shall be able to present the information referred to in subsection 10 years after they have received or delivered measuring instrument.

Section 4 - Requirements for notified bodies in conformity assessment procedures under the EEA Agreement

§ 4-20. Designation of Notified Body Undertakings shall perform duties as a Notified Body shall be appointed tasks by the Ministry of Fisheries Ministry under the Act 16 June 1994 no. 20 concerning notified bodies or by designating authority in another EEA country. Notified body shall be notified and published in the European Economic Area and have an identification number.
Notified bodies designated, shall meet the requirements for notified bodies in paragraph 4 and the Act of 16 June 1994. 20 concerning notified bodies. Bodies that meet the criteria in the relevant harmonized standards or parts thereof which have been published referring to the Official Journal, shall be presumed to meet the requirements of section 4, provided that the requirements covered by the standards.

§ 4-21. Requirements for application for designation application for designation shall be accompanied

1.
Description of the conformity assessment activities,

2.
It or the conformity assessment modules and measuring instruments, the notified body which it claims to be competent for, and

3.
An accreditation certificate issued by a national accreditation body confirming that the notified body meets the requirements of § 4-22 to § 4-29, if this exists. If an accreditation certificate can not be presented, the notified body must provide detailed designating authority all documentation necessary to verify, confirm and regularly supervise that body meets the requirements of §§ 4-22 to 4-29.

§ 4-22. Impartiality and impartiality Notified Body Notified body shall be a third-party body that is independent of the organization or the measuring instruments it considers.
Authority, its management and staff that perform tasks relating to conformity assessment shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of the measuring instruments of the inspecting, and not representative of any of these. This does not need the use of assessed measuring instruments for the notified body or the use of measuring instruments for personal purposes. The body must not belong to a craft or trade association that represents companies involved in the design, production, procurement, installation, use or maintenance of measuring instruments which it assesses, unless it can be demonstrated that the body is independent and that there are no conflicts of interest related to the task as a Notified body.
Authority and their personnel shall be free from all influences and motives, particularly financial, which might influence their judgment or the results of their conformity assessment, especially from persons or groups of persons with an interest in the results of the assessments.

It must be ensured that the body, its director and staff are impartial. Remuneration to the Authority's management and staff responsible for carrying out tasks relating to conformity assessment shall not depend on the number of tasks performed, or the results of such tasks.
A notified body, its management and staff responsible for carrying out conformity assessment activities shall not be directly involved in the design, manufacture, marketing, installation, use or maintenance of measuring tools, or represent the parties involved in such activities. They shall not engage in activities that may be in conflict with their objectivity and integrity in connection with the conformity assessment activities for which they are designated to do. Except for non-automatic weighing instruments, does not exclude this possibility of exchange of technical information between the manufacturer and the body in connection with the conformity assessment activities.

§ 4-23. Requirements for subcontracting and the company If a Notified Body assigns specific tasks relating to conformity assessment of a subcontractor or a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements of § 4-22, § 4-23 subsection, § 4-24 § 4-26, § 4-27 and § 4-28. The conformity assessment body shall notify the designating authority about this.
Notified bodies shall assume full responsibility for the tasks performed by the subcontractor or the company, wherever these are established.
Tasks can only be transferred to third parties or the company if the customer has given his consent.
Notified bodies shall keep the relevant documents concerning the assessment of the subcontractor's or the company's qualifications and the work carried out by them in accordance with Appendix 1, available to the designating authority.
Body shall ensure that activities of its subsidiaries or affiliates do not affect the body's confidentiality, objectivity or impartiality in relation to their conformity assessment activities.

§ 4-24. Competence Notified Body The conformity assessment shall be carried out in accordance with Annexes 1 and with the highest degree of professional integrity and the necessary expertise in metrology. The body must be able to ask the relevant documents regarding the assessment of the subcontractor's qualifications and the work he performs in accordance with this regulation, the disposal of designating authority.
Body must be able to carry out all the conformity assessment tasks for which it is designated, whether these tasks are carried out by the body itself or on its behalf and under its responsibility. It shall have at its disposal the necessary staff with technical expertise and the necessary experience to carry out conformity assessment, as well as its own procedures for conformity assessment carried out, ensuring transparent and reproducible assessments. Notified body shall have the necessary funds to perform the technical and administrative tasks conformity assessment involves a satisfactory manner, and access to necessary equipment or facilities.

§ 4-25. Requirements for the notified body carrying out the conformity assessment Conformity assessments shall be carried out in a manner proportionate to the goal, so that economic actors not imposed unnecessary burdens. The notified body shall conduct its operations so that due consideration is given to

A)
size of the entity,

B)
sector in which it conducts its business,

C)
its structure,

D)
complexity of the current måleredskapets technology and

E)
production process mass or serial touch.

In this connection they shall nevertheless comply with the degree of rigor and protection required for the measuring instrument shall be in accordance with these regulations and the instrument-specific regulations.
The notified body shall require the manufacturer to take appropriate corrective measures and shall not issue a certificate of conformity if it finds that the manufacturer has not fulfilled

A)
requirements in the instrument-specific regulations or

B)
corresponding harmonized standards, normative documents or other technical specifications.

A Notified Body in connection with verification of compliance by the issuance of a certificate find that measuring instrument no longer complies with the requirements shall require the manufacturer to implement appropriate corrective measures, if necessary, suspend or revoke the certificate.
If corrective measures are not taken or do not have the required effect, the notified body restrict, suspend or withdraw any certificates, whichever is appropriate.


§ 4-26. Requirements for staff in Notified Body Authority staff responsible for carrying out tasks relating to conformity assessment shall be

A)
solid technical and vocational training that covers all conformity assessment tasks which it is designated,

B)
satisfactory knowledge and understanding of the rules applicable to the tasks it performs, and adequate experience to carry out these tasks, as well as about the relevant harmonized standards and normative documents and

C)
necessary capacity to draw up the certificates, records and reports demonstrating that the tasks are performed.

Body shall participate in, or ensure that the staff responsible for carrying out tasks relating to conformity assessment, information

A)
the relevant standardization activities and

B)
activities of the established coordination group for notified bodies. Authority shall apply the administrative decisions and documents that the coordination group prepares for guidance.

§ 4-27. Requirements for insurance Notified Body The body must take out liability insurance if its civil liability is not covered by the state.

§ 4-28. Confidentiality Notified Body Authority staff are bound by confidentiality with regard to all information obtained in connection with the exercise of duties under this Regulation, except the relevant Norwegian authorities.

§ 4-29. The obligation to inform others Notified bodies shall inform the designating authority

A)
any refusal, limitation, suspension or revocation and a prohibition on the sale of a certificate,

B)
any circumstances affecting the scope or terms of appointment,

C)
any request for information which it has received from market surveillance authorities regarding conformity assessment activities,

D)
upon request, conducted conformity assessment activities.

Notified bodies shall provide the other bodies designated in accordance with Directive 2014/32 / EC and Directive 2014/31 / EU and carrying out similar conformity assessment activities for the same measuring instruments, relevant information relating to negative and, on request, positive conformity assessment results.

Section 5 - Requirements for national conformity assessment

§ 4-30. National conformity assessment National conformity assessment means measuring instruments shall be type approved and the first time approved by the Metrology before they are offered for sale or sold unless Metrology has decided otherwise in the instrument-specific regulations. New type of measuring instrument or measuring instruments in new or changed construction requires separate approval.
Initial Approval may still be made after the measuring instrument has been installed, if

A)
måleredskapets properties and construction makes it impossible to perform control until they are mounted,

B)
measuring instrument is approved or seller has applied for approval, and

C)
seller provides the necessary validation as soon as possible.

Initial approval must invariably be carried out before the measuring instrument is used. Metrology may waive this requirement in certain cases if it is deemed prudent.

§ 4-31. Application for approval by national conformity assessment written application for approval submitted to metrology. The application shall include the necessary documentation so that Metrology can process your application.
If it is necessary to process the application, Justervesenet ask the applicant exhibiting a copy of the measure instrument for examination and testing. Measuring The instrument shall then be presented with all the equipment that is normally destined for it. If the application concerns a measuring instrument which, by their size, assembly or other reason can only be examined at the place where it according to the application's location, the examination shall be made there. The applicant must provide any dismantling and assemblies and to present any necessary assistance available if metrology requests.

§ 4-32. Responsible for Conformity Assessment manufacturer or his authorized representative shall ensure that measuring instruments made available on the market with valid conformity assessment and conformity marking according to the requirements of the regulation.
Anyone who makes measuring instruments available on the market, is responsible for ensuring that they only deal with measuring instruments which are intended by the requirements of the regulation.

§ 4-33. The scope of type approval by national conformity assessment type approval may each measuring instrument group limited to apply

A)
specific types or structures in general or only those from a specified manufacturer, or

B)
only a single or a specific number of measuring tools of a certain type.


The type approval can also be restricted to apply only to the use of the measuring instrument to the particular use or trade to designated enterprises, to certain parts of the country or in limited time.

Section 6 - Final provisions

§ 4-34. Fine Violation of the provisions of this chapter may result in imposition of fines meted out under the provisions of Chapter 7.

Chapter 5 - Requirements for measurement and measuring instruments during use

§ 5-1. User responsibility The user is responsible for ensuring that a measuring instrument meets the requirements of the regulations, conformity declaration, instrument-specific regulations and other requirements laid down in and pursuant to the Law on measurement units, measurement and standard time. Measuring tool may be used only if it is approved under the provisions of chapter 4 before it was sold.

§ 5-2. Supervision Metrology supervision during use may be intermittent. For periodic supervision created supervision period at least have to run between two periodic inspections. Supervision period calculated in calendar year, and the audit can by efficiency considerations are made at any time during the calendar year. The scheme does not preclude that other supervision carried out during the supervision period.
By efficiency considerations Justervesenet make exceptions created supervision period when Metrology is in the area to perform audits or other work pursuant to the Law on measurement units, measurement and standard time.
Metrology determines how the audit will take place. Measuring The instrument must be checked where it is installed when

A)
measuring instrument is fixed or difficult to move because of their size, weight or sensitivity

B)
measuring tool must be located where it will be used for the audit to be carried out.

For mobile measuring instrument Justervesenet decide that supervision should be carried out in the designated location. User will be notified about the place and time of the audit at least two weeks prior to the audit to take place.
Authority may otherwise be made in Metrology premises and measuring instrument produced when fully completed able to be controlled.
The user must provide the tarermaterialet and the work help that metrology need of supervision.
If the user does not contribute to or hinder the audit, the measuring instrument is illegal to use as a basis for calculating a financial settlement or for other purposes which are subject to requirements pursuant to Chapter 3.
user or owner of a measuring instrument is responsible for equipment metrology user during a session stored and handled properly until Metrology even takes care of the equipment.

§ 5-3. The documents shall be submitted by the Authority Upon audit, the user shall submit the declaration of conformity or the national type approval and other documentation metrology demands. Discloses no user documents, Justervesenet stipulate that the measurement instrument can not be used as a basis for calculating a financial settlement or other purposes which are subject to requirements pursuant to Chapter 3.

§ 5-4. Metrology empowered to impose internal metrology may by regulations or individual impose user requirements for internal control, when conditions are right the user.

§ 5-5. Duty of due care, correction and message Is there reason to believe that a measuring instrument no longer meets the requirements of the dispenser, the user should immediately clarify and possibly remedied. Can not violations of the requirements addressed, the user should immediately take measure instrument out of operation and secure it so it can not be confused with measuring instruments that meet the requirements of the dispenser.
Is the seal broken or måleredskapets significant metrological characteristics affected, measuring tool is not used as a basis for calculating a financial settlement or other purposes which are subject to requirements under Chapter 3 before the user has notified Metrology. The user must be able to document the notification of Metrology. After Metrology received the message Justervesenet conduct a follow-up session.
When a decision that a measuring instrument complies with the prescribed requirements, has lapsed, cf. Law on measurement units, measurements and Standard Time § 9, second paragraph, can not measure the implement used as a basis for calculating a financial settlement or other purposes which are subject to requirements pursuant to Chapter 3.
Whoever repairs, maintains or performing other work on a measuring instrument, shall notify the Metrology if the work breaks a seal or provide risk that measuring instrument no longer meets the requirements for measuring equipment. Metrology may by regulations make exceptions to this section.

§ 5-6. User Obligations The user must ensure that the measuring instrument is operated within the specified minimum and maximum load. Metrology may by regulation or individual decision make exceptions from this section.

A measuring tool can not be used as a basis for calculating the financial settlement or other purposes in accordance with Chapter 3 when measuring tool or equipment that is associated with the measuring tool is changed so that it is possible to manipulate the measurement result.

§ 5-7. Marking of measuring instrument metrology can mark the test tool with a brand that expresses the measurement tool meets the regulatory requirements.
Metrology can mark measuring instrument with a mark that identifies measurement tool.

§ 5-8. Rectification and temporary use permit Satisfies not a measuring instrument requirements for measuring instrument, Justervesenet set a deadline for rectification, cf. Law on measurement units, measurement and standard time § 26. Measuring tool may temporarily used until this deadline. Repairs not user measuring tool and notify the Metrology in accordance with § 5-5 second paragraph within the deadline can not measure tool used as a basis for calculating a financial settlement or other purposes in accordance with Chapter 3.

§ 5-9. Permission to use the user equipment by the audit can be agreed that the Metrology uses the user equipment for the implementation of the audit if Metrology considers it appropriate. Metrology puts the necessary requirements.

§ 5-10. Fine Violation of the provisions of this chapter may result in imposition of violation charges metered by the provisions of Chapter 7.

Chapter 6 - Fees and charges

§ 6-1. Fees for processing the application for approval The applicant for type approval or initial approval under § 4-30, must pay a fee to metrology to $ 4,060 per attendance at the user site and $ 1880 per hour Metrology use on site. Treat the application for approval in Metrology premises, the fee is US $ 1620 per hour.

§ 6-2. Annual fee for supervision Whoever uses measuring instrument or performing measurements as indicated in the table and doing business as of March 1, shall pay the following annual fees:
Table 11. Annual fee

Measuring Tools / measurements
Category
Annual fee of £

Scales in grocery stores (per store)
-
1460

Balances in postal services and post office (per store / post office)

280

Taximeters (per measuring instrument)
-
1960

Measuring system for continuous and dynamic measurement of liquid gas (LPG) (per measuring instrument)
-
4500

Supply meters (per grid company)
with under 10,000 measuring points
8000

With 10 000-50 000 measuring points
28,000

With over 50,000 measuring points
60,000

Small & Medium measuring systems for continuous and dynamic measurement of liquids other than water at gas stations and similar (per fuel plant)
with less than 500 000 l traded fuel per year (excluding LPG)
670

500 000-2 000 999 l traded fuel per year (excluding LPG)
3600

With 2001 000-4 000 000 l traded fuel per year (excluding LPG)
8850

With more than 4 million l traded fuel per year (excluding LPG)
18,000

This provision does not apply to measuring instruments used on Svalbard. For measuring instruments as specified in Table 11 and used on Svalbard, paid fees in accordance with § 6-3.

§ 6-3. Annual fee for supervision of fish landing Company that owns one or more fish landing where it carried out measurements in connection with the receipt and packing of fish and possibly packaging of processed product of received fish shall pay annual fees for these measurements. This does not apply to companies that receive less than 10 tonnes of wild fish per year in the first hand.
The annual fee is 0.5 per thousand of the company's turnover as stated in previous annual accounts but not more than £ 300 000. The annual fee of less than £ 1000 are not collected.
Company that are not covered by submission obligation in the Accounting Act § 8-2, shall by 30 June each year uninvited submit accounts for the preceding year to metrology.
For newly established enterprises submitted revenue figures per 30 November unsolicited Metrology latest on December 5th year of establishment. Revenue by November 30 shall apply to the calculation of supervisory fee in foundation year.
Enterprises liquidated during supervision year is obliged to immediately inform Metrology about this. Metrology event of such notification to provide clearing of supervision fee. The tax is calculated on the basis of turnover in the preceding business year but reduced proportionally so that the month of the liquidation of the business came into metrology is the last month as part of the basis for the proportionate curtailment of tax.

If the company can demonstrate that part of the turnover stems from activities other than that stated in the first paragraph shall make such sales is deducted from the tax base. The documentation must be certified by an auditor or external accountant. For companies without submission obligation accounting registry cf. Subsections, such documentation shall be submitted along with the financial statements.
Metrology is authorized to establish further deadlines and content of the documentation requirements acc. present determination.

§ 6-4. Fees for supervision Whoever uses measuring instrument and perform measurements as specified in the table shall pay the following fee per attendance at the place and hourly charge Metrology uses the audit:
Table 12. Fee rates

Measuring Tools / measurements
Capacity
fee per attendance in £
Hourly fee in £

Midsize weights
From 500 kg to 5000 kg
7840
1960

Heavyweight
Over 5000 kg
15,880
1960

Store measurement systems for continuous and dynamic measurement of liquids other than water
than 400 l / min
4580
2120

Other measuring instruments and measurements, and supervision that does not involve transport and use of special measuring equipment

4200
1960

§ 6-5. Audit of internal control and prepackages For supervision of internal control and supervision requirements for prepackages, the user shall pay a fee for Metrology to $ 4,200 per attendance at the user site and $ 1890 per hour Metrology uses the audit. Performed the audit in Metrology premises, the fee is US $ 1680 per hour.

§ 6-6. Fee findings of violations of the regulations (deviation s) Covering an audit violation of the requirements of or pursuant to the Act on 26 January 2007 no. 4 to units of measurement, measurement and standard time, the user shall pay fees

A)
measurements associated with the manufacture of ready-packed in fish landing and weight in fish landing to $ 5,000 per package line and per measuring instrument

B)
taximeters, scales in grocery stores, weights in post office, medium weights and heavy weights, measuring systems for continuous and dynamic measurement of liquid gas (LPG), small and medium-sized measuring systems for continuous and dynamic measurement of liquids other than water at gas stations, large measuring systems for continuous and dynamic measurement of liquids other than water and other measuring instruments and measurements with £ 2640 per measuring instrument

§ 6-7. Inspection fees pursuant to § 5-5 second and fourth paragraphs of heavyweight and large measuring systems for continuous and dynamic measurement of liquids other than water If Metrology receives notification pursuant to § 5-5 second and fourth paragraphs of heavyweight or large measuring systems for continuous and dynamic measurement of liquids other than water, and use or who have performed the repairs, maintenance or other work on the measuring tool, not have the necessary equipment to control the measuring instrument meets the requirements for measuring gear, the user pay a fee per attendance at the place and hourly charge Metrology uses the Authority, as defined in § 6.3, table 12.

§ 6-8. Additional costs If the user's activities makes Metrology incurs costs in overseeing that the fee or charge is intended to cover, Justervesenet plus fixed fee and / or fee in individual impose use to cover these costs.

§ 6-9. Fee for no-shows Failing a user to face up to a required supervision, the user shall pay a fee of $ 2 110.

§ 6-10. Calculation of hourly fee when calculating the hourly fee under § 1.6, § 6.3 and § 4.6 paid the fee for a commenced hour per commenced quarter.

§ 6-11. Requirements and late fee charges and fees to be paid for claims of Metrology.
Pays the fee or charge too late and there will be roused in payment will incur late charges by law 13 May 1988 no. 26 on debt collection and other collections of overdue claims § 19 and Regulation on 14 July 1989 no. 562 to the Debt Collection Act § 1-2.

Chapter 7 - Rules relating to the assessment and consideration of the violation charge

§ 7-1. Determination on fixed rates Metrology can impose administrative fine of 10 times the hourly fee in § 6-1 second sentence in cases of willful or negligent violation of the following provisions of the Law on measurement units, measurement and standard time or regulations issued pursuant to these provisions:

A)
§ 17 subsection on information and reporting obligations

B)
§ 18 on obligations for those who have responsibilities with measuring instruments and measurements

C)
§ 19 on labeling requirements when using contravenes the requirements

D)
§ 22 - § 24 of unimpeded access, disclosure and practical assistance and facilitating the audit.


Case of violation of the Law on measurement units, measurement and standard time § 25 on disclosure Justervesenet impose a fine of five times the court fee.

§ 7-2. Determination based on criteria and maximum amounts Metrology can impose a fine of up to 10 percent of the company's turnover, but in no case less than 10 times an hour fee specified in § 6-1 second sentence in cases of willful or negligent violation of the Law on measurement units, measurement and standard time || |
A)
Chapter 3 requirements for sales

B)
chapter 4 on requirements when using measuring instruments

C)
Chapter 5 on claims by citing metrics

D)
§ 17 subsections on obligations to comply with regulations

E)
§ 19 on labeling requirements when selling violates requirements.

The same applies to infringements of individual decisions made pursuant to paragraphs.
With turnover means business revenue last fiscal year. With operations means any private or public entity or private individual performs or is responsible for an activity covered by the Law on measurement units, measurement and standard time.
By sentencing shall inter alia be given to:

A)
Nature of the infringement

B)
reason or motive for the violation

C)
The effects of the infringement

D)
Economic profits or other benefits as a result of the infringement

E)
Whether there is repeated infringements.

§ 7-3. Payment deadline to pay violation fines is four weeks from the order unless otherwise specified. If violation fine is not paid when due, interest on late payments in accordance with Law 17 December 1976 no. 100 relating to interest on overdue payments
Final decision on administrative penalties are enforceable by execution.

Chapter 8 - Final provisions

§ 8-1. Transitional provisions for measuring instruments covered by Directive 2004/22 / EC Measuring Tools mentioned in § 4-2 first paragraph and type-approved before 30 October 2006, can still be made available on the market the first time until the period of validity of type approval lapses, but in no case after 30 October 2016.

§ 8-2. Commencement and repeal of other regulations Regulations come into force on 1 January 2008.
From the same date

A)
Regulation of 10 June 1977 no. 1 to units of measurement

B)
Regulation of 23 December 1994 no. 4120 about adjusting fees etc..

C)
Regulation on 24 August 1999 no. 964 on adjusting

D)
Regulation on 5 December 2001 no. 1339 of repository normals adjustment

E)
Regulation of 8 June 1995 no. 550 on alcohol tables

F)
Regulation of 8 June 1995 no. 551 e-marking of prepackages

G)
Regulation of 8 June 1995 no. 552 on measuring the hectolitre mass of grain

H)
regulation on 25 November 1996 no. 1173 relating to bottles used as measuring containers

I)
regulation of 26 April 2006 no. 454 on requirements for conveyor scales

J)
regulation of 26 April 2006 no. 455 on requirements for automatic discontinuous summation weights (summing container weights)

K)
regulation of 26 April 2006 no. 466 on requirements for flow meters (for liquids other than water)

L)
regulation of 26 April 2006 no. 467 on requirements for material measurements

M)
regulation of 26 April 2006 no. 468 on requirements for electricity meters sold

N)
regulation of 26 April 2006 no. 469 on requirements for length measurement instruments

O)
regulation of 26 April 2006 no. 470 on requirements for automatic train weights

P)
regulation of 26 April 2006 no. 481 on requirements for instruments for automatic weighing of individual quantities (catch weights)

Q)
regulation of 26 April 2006 no. 482 on requirements for heat meters

R)
regulation of 26 April 2006 no. 497 on requirements for exhaust gas gauges

S)
regulation of 26 April 2006 no. 498 on requirements for water meters

T)
regulation of 26 April 2006 no. 499 on requirements for instruments to multidimensional measurements (multi-dimensional gauges)

U)
regulation of 26 April 2006 no. 500 on requirements for automatic gravimetric filling machines

V)
regulations March 24, 2006 no. 368 on the extension of the scope of Law 31 October 1946 No.. 2 about weights and measures.

Appendix no. 1 to regulations on measurement units and measurement, cf. Regulations § 4-6.

Compliance Modules

Module B - EC type examination
Module D - Compliance with the type based on quality assurance of the production process
Module D1 - Quality assurance of the production process
Module E - Compliance with the type based on quality assurance of final product
Module E1 - quality assurance by inspection and testing of the final product
Module F - Initial verification
Module F1 - Conformity based on product verification
Module G - Conformity based on unit verification
Module H - Conformity based on full quality assurance

Module H1 - Conformity based on full quality assurance and design examination

Module B - EC type examination

1.
"EC type examination" is the part of the conformity assessment procedure whereby a notified body examines a måleredskaps technical design and ensures and declares that måleredskapets technical design meets the requirements of these regulations and the instrument-specific regulations.

2.
EU-type examination may be carried out on one of the following ways:

A)
examination of a specimen of the complete measuring instrument that is representative of the planned production (product testing)

B)
assessment of the technical documentation's suitability for measuring tool by examination of the technical documentation and supporting documentation referred to in paragraph 3, and examination of specimens, representative of the production envisaged, of one or more critical parts of the measuring instrument ( combination of product testing and design type examination)

C)
assessment of the suitability of måleredskapets technical design by examination of the technical documentation and supporting documentation referred to in paragraph 3, without examination of a specimen (design type examination).

The notified body decides suitable process and the necessary proofs.

3.
Application for EC type examination shall be submitted by the manufacturer to only one notified body, chosen by the manufacturer.

The application shall include the following:

A)
manufacturer's name and address and the representative's name and address if it has submitted your application,

B)
a written declaration that the same application has not been lodged with another notified body,

C)
the technical documentation described in § 4-12. The documentation shall make it possible to assess the measure tool is in accordance with the requirements of these regulations and the instrument-specific regulations, and shall include an adequate analysis and assessment of risk. The technical documentation shall specify the relevant applicable requirements, and, to the extent it is relevant for such assessment, cover måleredskapets design, production and function.

Where relevant, the application shall also contain

D)
specimens representative of the production envisaged. If it is necessary to carry out the test program, the notified body may require further specimens,

E)
additional documentation for the technical structure suitability. This additional documentation must mention any relevant documents that have been used, in particular where the relevant harmonized standards and / or normative documents are not used in full and shall, if appropriate, include the results of tests carried out in accordance with other relevant technical specifications and the manufacturer appropriate laboratory, or by another testing laboratory on behalf of the manufacturer and the manufacturer's responsibility.

4.
The notified body shall:

For measuring tool;

4.1.
examine the technical documentation and supporting documentation to assess whether måleredskapets construction is suitable.

For the specimens;

4.2.
verify that the specimens were produced in accordance with the technical documentation and determine which components are designed in accordance with the relevant provisions of the relevant harmonized standards and / or normative documents, and which components are designed by other relevant specifications,

4.3.
perform or have perform the appropriate examinations and tests, in those cases the manufacturer has chosen to use the solutions in the relevant harmonized standards and normative documents, to check whether these solutions are used correctly

4.4.
perform or have perform the appropriate examinations and tests, in those cases the manufacturer has chosen not to use the solutions in the relevant harmonized standards and / or normative documents but other relevant technical specifications, to check whether the solutions adopted by the manufacturer meet the requirements of this Regulations and the instrument-specific regulations

4.5.
consultation with the manufacturer where the necessary examinations and tests to be performed

For other parts of the measuring instrument;

4.6.
examine the technical documentation and supporting documentation to assess whether the technical design of the other parts of the measuring instrument is suitable. This is not required for non-automatic weighing instruments

5.
The notified body shall prepare an evaluation report on the activities carried out under paragraph 4 and the results thereof. Without prejudice to the provision in § 4-28, the agency shall fully or partially only disclose the contents of this report with the manufacturer's consent.

6.

Where the type meets the requirements of the dispenser of these regulations and the instrument-specific regulations, the notified body must issue an EC type examination certificate to the manufacturer. The certificate must contain the name and address of the manufacturer and, where appropriate his representative, conclusions of the examination, any conditions for its validity and the necessary data for identification of the measuring instrument. It can be attached one or more attachments to EC type examination certificate.

EC type examination certificate and its annexes shall contain all relevant information necessary to conduct an assessment of whether produced measuring instruments is consistent with the type and make it possible to make control during use.
To make it possible to assess whether they produced the measuring equipment is in accordance with the examined type with regard to reproducibility of the metrological characteristics shall further contain

A)
instrumenttypens metrological characteristics,

B)
measures required to ensure that the measuring instrument is intact (sealing, identification of software, etc..)

C)
information on other elements necessary to identify measurement tools and control måleredskapets visual external conformity with the type,

D)
any specific information necessary to verify produced måleredskapers properties

E)
for a sub-unit, all information necessary to ensure compatibility with other sub-assemblies or measuring instruments

The previous section does not apply to non-automatic weighing instruments.
EU-type examination certificate shall have a validity of ten years from the date of issue and can be renewed for successive ten-year periods. For non-automatic weighing instruments which construction is substantially altered, for example due to the use of new technology, EU typeprøvingssertifikatets validity period limited to two years and extended by three years.
If the notified body finds that the type examination certificate can not be issued, the applicant shall disclose that fact, and the notified body shall provide detailed reasons.

7.
The notified body shall keep itself informed of any changes in the generally recognized technological condition, indicating that the approved design no longer complies with the relevant requirements of the compliance of these regulations and the instrument-specific regulations, and shall determine whether such changes require further investigation. Authority shall then inform the manufacturer thereof.

8.
The manufacturer must inform the notified body that holds the technical documentation with respect to the EC type examination certificate of all modifications to the approved type that may affect måleredskapets accordance with the requirements of these regulations and the instrument-specific regulations or validity terms. Such changes require additional approval in the form of an addition to the original EC type examination certificate.

9.
Each notified body shall inform its designating authority EC type examination certificates and / or amendments thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its designating authority a list of such certificates and / or amendments thereto which is off, suspended or otherwise limited.

Notified Body for non-automatic weighing instruments shall also inform other notified bodies about the EC-type examination certificates and / or additions to these, which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, as certificates it has issued.
European Commission, Member States and the other notified bodies may on request obtain a copy of the EC type examination certificate and / or amendments thereto. The European Commission and Member States on request obtain a copy of the technical documentation and the results of surveys conducted by the notified body.
The notified body shall keep a copy of the EC type examination certificate, additions and amendments thereto, as well as the technical documentation from the manufacturer, until the expiry of its validity period.

10.
The manufacturer shall keep a copy of the EC type examination certificate with annexes and additions as well as the technical documentation at the disposal of the national authorities for ten years after the measuring instrument was made available on the market first.

11.
Manufacturer's Representative may submit the application referred to in paragraph 3 and carry out the duties mentioned in paragraph 8 and 10, if so specified in the authorization.

Module D - Compliance with the type based on quality assurance of the production process

1.

"Compliance with the type based on quality assurance of the production process' is the part of the conformity assessment procedure whereby the manufacturer fulfills the obligations in paragraph 2 and 5 and ensures and declares on own responsibility that the affected measuring instruments are in compliance with EC type examination certificate and satisfy the relevant requirements of these regulations and the instrument-specific regulations.

2.
production

The manufacturer shall apply an approved quality system for production, control of the final product and testing of the affected measuring instrument as defined in Section 3, and is subject to follow-up paragraph 4.

3.
quality

3.1.
The manufacturer shall submit an application for assessment of his quality on the actual measuring instruments to a freely chosen Notified Body.

The application shall include the following:

A)
manufacturer's name and address and the representative's name and address if it has submitted your application,

B)
a written declaration that the same application has not been lodged with another notified body,

C)
all relevant information for the relevant instrument category,

D)
documentation for quality system

E)
the technical documentation for the approved type and a copy of the EC type examination certificate.

3.2.
The quality system must ensure that the measuring equipment is in conformity with the type as described in the EC type examination certificate and with the relevant requirements of these regulations and the instrument-specific regulations.

All the elements, requirements and provisions adopted by the manufacturer into consideration shall be documented in a systematic and orderly manner in the form of quality policies, procedures and instructions. This quality system documentation must make it possible to interpret the quality programs, plans, manuals and records in a uniform manner.
Particular, it shall contain a full description of

A)
quality objectives and the organizational structure, responsibilities and powers with regard to product quality,

B)
techniques for manufacturing, quality control and quality assurance as well as processes and systematic measures used,

C)
examinations and tests to be carried out before, during and after manufacture, and the frequency they performed with

D)
records, such as inspection reports and test data, calibration data, qualification reports for relevant staff, etc.,

E)
measures for monitoring the planned product quality and efficient operation of the quality system

3.3.
The notified body must assess the quality system to determine whether it meets the requirements specified in section 3.2. It shall presume compliance with these requirements in respect of the components of a quality system that complies with the corresponding specifications of the relevant harmonized standard.

In addition to experience in quality management systems must control team composed of at least one member with experience of assessment in the relevant instrument area and the current instrument technique, and have knowledge of the relevant requirements of these regulations and the instrument-specific regulations. The inspection shall include an inspection visit to the manufacturer's premises.
Control team will examine the technical documentation referred to in Section 3.1. letter e, to verify that the manufacturer fail to determine the relevant requirements of these regulations and the instrument-specific regulations, and conduct the investigations necessary to ensure that the measuring instrument complies with these requirements.
The result shall be communicated to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3.4.
The manufacturer undertakes to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and effective.

3.5.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall assess any changes and decide whether the amended quality system will still meet the requirements specified in section 3.2. Or whether a reassessment is required.
It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4.
The notified body responsible for supervising

4.1.
The purpose of the follow-up is to ensure that the manufacturer duly fulfills the obligations arising out of the approved quality system.

4.2.
The manufacturer shall for control purposes allow the notified body access to inspect production, inspection, testing and storage conditions, and provide all necessary information, in particular:

A)
quality system documentation,


B)
quality records, such as inspection reports and test data, calibration data, qualification reports for relevant staff etc.

4.3.
The notified body shall carry out regular checks to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report against the manufacturer.

4.4.
Furthermore, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out or let carry out instrument tests to check that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests are performed, a test report.

5.
Conformity marking and EC Declaration

5.1.
The manufacturer shall affix the CE marking, the supplementary metrology marking referred to in this regulation and, in agreement with the notified body referred to in paragraph 3.1., The latter's identification number to each individual measuring instrument that complies with EC type examination certificate and satisfy the relevant requirements of these regulations and the instrument-specific regulations.

5.2.
The manufacturer prepares a written EU declaration of conformity for each instrument type and store it so that it can be made available to the national authorities for ten years after the measuring instrument has been made available on the market first. EU declaration of conformity shall identify the instrument type it has been drawn.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
A copy of the EC declaration of conformity to accompany each measuring instrument that is made available on the market first. This requirement may be interpreted as applying to a party or a transmission rather than for the individual measuring instrument, in cases where a large number of measuring instruments are delivered to a single user. This section does not apply to non-automatic weighing instruments.

6.
The manufacturer shall for ten years after the measuring instrument was first made available on the market, keep at the disposal of the national authorities

A)
documentation referred to in Section 3.1.,

B)
information about approved amendments referred to in Section 3.5.,

C)
results and reports from the notified body referred to in Section 3.5., 4.3. and 4.4.

7.
Each notified body shall inform its designating authority if adopted approvals or recalls of quality system, and shall, periodically or upon request, make a list of quality system approvals granted, refused or withdrawn, provided for its designating authority.

8.
Authorized Representative

Manufacturer obligations under Section 3.1., 3.5., 5 and 6 may, on his behalf and responsibility, are fulfilled by the manufacturer's authorized representative, if so specified in the authorization.

Module D1 - Quality assurance of the production process

1.
"Quality assurance of the production process' is the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in paragraphs 2, 4 and 7, and ensures and declares on own responsibility that the affected measurement tool meets the relevant requirements of these regulations and the instrument-specific regulations.

2.
Technical documentation

The manufacturer shall establish the technical documentation described in § 4-12. The documentation shall make it possible to assess the measure tool complies with the relevant requirements of these regulations and the instrument-specific regulations, and shall include an adequate analysis and assessment of risk. It shall specify the relevant requirements, and to the extent it is relevant for such assessment, cover måleredskapets design, production and function.

3.
The manufacturer shall keep the technical documentation at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first.

4.
production

The manufacturer shall apply an approved quality system for production, control of the final product and testing of the affected measuring instrument as defined in paragraph 5, and is comprised of the follow-up paragraph 6.

5.
quality

5.1.
The manufacturer shall submit an application for assessment of his quality system for the relevant measuring instrument to a freely chosen Notified Body.

The application shall include the following:

A)
manufacturer's name and address and the representative's name and address if it has submitted your application,

B)
a written declaration that the same application has not been lodged with another notified body,

C)
all relevant information for the relevant instrument category,

D)
documentation for quality system

E)
the technical documentation referred to in paragraph 2.


5.2.
The quality system must ensure that the measuring equipment is in compliance with the relevant requirements of these regulations and the instrument-specific regulations.

All the elements, requirements and provisions adopted by the manufacturer into consideration shall be documented in a systematic and orderly manner in the form of quality policies, procedures and instructions. This quality system documentation must make it possible to interpret the quality programs, plans, manuals and records in a uniform manner.
It shall include in particular an adequate description of

A)
quality objectives and the organizational structure, responsibilities and powers with regard to product quality,

B)
techniques for manufacturing, quality control and quality assurance as well as processes and systematic measures used,

C)
examinations and tests to be carried out before, during and after manufacture, and the frequency they performed with

D)
records, such as inspection reports and test data, calibration data, qualification reports for relevant staff, etc.,

E)
measures for monitoring the planned product quality and the effective operation of the quality system.

5.3.
The notified body must assess the quality system to determine whether it satisfies the requirements referred to in Section 5.2. It shall assume protection requirements with regard to quality components of the system in accordance with the corresponding specifications of the relevant harmonized standard.

In addition to experience in quality management systems, at least one member of the control team have experience with evaluation in the relevant instrument area and the current instrument technique, and have knowledge of the relevant requirements of these regulations and the instrument-specific regulations. The inspection shall include an inspection visit to the manufacturer's premises.
Control team will examine the technical documentation referred to in paragraph 2 to verify that the manufacturer fail to determine the relevant requirements of these regulations and the instrument-specific regulations, and conduct the investigations necessary to ensure that the measuring instrument is in compliance with these demands.
The result shall be communicated to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

5.4.
The manufacturer undertakes to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and effective.

5.5.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the amended quality system still meets the requirements referred to in Section 5.2., Or whether a reassessment is required.
It must notify the manufacturer of its decision. The notification must contain the conclusions of the investigation and the reasons for the decision.

6.
The notified body responsible for supervising

6.1.
The purpose of monitoring is to ensure that the manufacturer duly fulfills the obligations arising out of the approved quality system.

6.2.
The manufacturer shall for control purposes, allow the notified body access to inspect production, inspection, testing and storage conditions, and provide all necessary information, in particular

A)
quality system documentation,

B)
the technical documentation referred to in paragraph 2

C)
quality records, such as inspection reports and test data, calibration data, qualification reports for relevant staff etc.

6.3.
The notified body shall carry out regular checks to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report against the manufacturer.

6.4.
Furthermore, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out or let carry out instrument tests to check that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests are performed, a test report.

7.
Conformity marking and EC Declaration

7.1.
The manufacturer shall affix the CE marking, the supplementary metrology marking referred to in this regulation and, under the notified body referred to in paragraph 5.1. their responsibilities, the latter's identification number to each individual measuring instrument that complies with these regulations and the instrument-specific regulations.

7.2.

The manufacturer shall draw up a written EU declaration of conformity for each instrument type. This must be kept so that it can be made available to the national authorities for ten years after the measuring instrument has been made available on the market first. It shall identify the instrument type it has been drawn.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
A copy of the EC declaration of conformity to accompany each measuring instrument that is made available on the market first. This requirement may be interpreted as applying to a party or a transmission rather than for the individual measuring instrument in cases where a large number of measuring instruments are delivered to a single user.

8.
The manufacturer shall for ten years after the measuring instrument was made available on the market the first time, make available to the national authorities:

A)
documentation referred to in Section 5.1.,

B)
information about approved amendments referred to in Section 5.5.,

C)
results and reports from the notified body referred to in Section 5.5., 6.3. and 6.4.

9.
Each notified body shall inform its designating authority approvals or recalls of quality systems, and shall, periodically or upon request, make the list of changes at the quality that is denied, suspended or otherwise restricted, accessible to its designating authority.

10.
Authorized Representative

Manufacturer obligations under paragraph 3, 5.1., 5.5., 7 and 8, on his behalf and responsibility, are fulfilled by the manufacturer's authorized representative, if so specified in the authorization.

Module E - Compliance with the type based on quality assurance of final product

1.
"Compliance with the type based on quality assurance of final product" is the part of the conformity assessment procedure whereby the manufacturer fulfills the obligations in paragraphs 2 and 5, and ensures and declares on own responsibility that the affected measuring instruments are in conformity with the type described in the EC type examination certificate and the requirements these regulations and the instrument-specific regulations.

2.
production

The manufacturer shall apply an approved quality control of the final product and testing of the affected measuring instruments as defined in Section 3, and is subject to follow-up paragraph 4.

3.
quality

3.1.
The manufacturer shall submit an application for assessment of his quality regarding appropriate measuring instruments to a freely chosen Notified Body.

The application shall include the following:

A)
manufacturer's name and address and the representative's name and address if it has submitted your application,

B)
a written declaration that the same application has not been lodged with another notified body,

C)
all relevant information for the relevant instrument category,

D)
documentation for quality system

E)
the technical documentation of the approved type and a copy of the EC type examination certificate.

3.2.
The quality system must ensure that the measuring equipment is in conformity with the type as described in the EC type examination certificate and with the requirements of these regulations and the instrument-specific regulations.

All the elements, requirements and provisions adopted by the manufacturer into consideration shall be documented in a systematic and orderly manner in the form of quality policies, procedures and instructions. This quality system documentation must make it possible to interpret the quality programs, plans, manuals and records in a uniform manner.
It shall include in particular an adequate description of

A)
quality objectives and the organizational structure, responsibilities and powers with regard to product quality,

B)
examinations and tests to be carried out after manufacture, and the frequency they performed with

C)
records, such as inspection reports and test data, calibration data, qualification reports for relevant staff, etc.,

D)
measures for monitoring the planned product quality and efficient operation of the quality system

3.3.
The notified body must assess the quality system to determine whether it meets the requirements specified in section 3.2. It shall presume compliance with these requirements in respect of the elements of a quality system that complies with the corresponding specifications of the relevant harmonized standard.

In addition to experience in quality management systems, at least one member of the control team have experience with evaluation in the relevant instrument area and the current instrument technique, and have knowledge of the relevant requirements of these regulations and the instrument-specific regulations. The inspection shall include an inspection visit to the manufacturer's premises.

Control team will examine the technical documentation referred to in Section 3.1. letter e, to verify that the manufacturer fail to determine the relevant requirements of these regulations and the instrument-specific regulations, and conduct the investigations necessary to ensure that the measuring instrument complies with these requirements.
The result shall be communicated to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3.4.
The manufacturer undertakes to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and effective.

3.5.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the amended quality system will still meet the requirements specified in section 3.2. Or whether a reassessment is required.
It must notify the manufacturer of its decision. The notification must contain the conclusions of the investigation and the reasons for the decision.

4.
The notified body responsible for supervising

4.1.
The purpose of monitoring is to ensure that the manufacturer duly fulfills the obligations arising out of the approved quality system.

4.2.
The manufacturer shall for control purposes allow the notified body access to inspect production, inspection, testing and storage conditions, and provide all necessary information, in particular

A)
quality system documentation,

B)
quality records, such as inspection reports and test data, calibration data, qualification reports for relevant staff etc.

4.3.
The notified body shall carry out regular checks to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report against the manufacturer.

4.4.
Furthermore, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out or let carry out instrument tests to check that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests are performed, a test report.

5.
Conformity marking and EC Declaration

5.1.
The manufacturer shall affix the CE marking, the supplementary metrology marking referred to in this regulation and, under the notified body referred to in paragraph 3.1. their responsibilities, the latter's identification number to each individual measuring instrument that complies with EC type examination certificate and satisfy the relevant requirements of these regulations and the instrument-specific regulations.

5.2.
The manufacturer prepares a written EU declaration of conformity for each type of instrument and store this at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first. It shall identify the instrument type it has been drawn.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
A copy of the EC declaration of conformity to accompany each measuring instrument that is made available on the market first. This requirement may be interpreted as applying to a party or a transmission rather than for the individual measuring instrument in cases where a large number of measuring instruments are delivered to a single user.

6.
The manufacturer shall for ten years after the measuring instrument was made available on the market the first time, make available to the national authorities:

A)
documentation referred to in Section 3.1.,

B)
information about approved amendments referred to in Section 3.5.,

C)
results and reports from the notified body referred to in Section 3.5., 4.3. and 4.4.

7.
Each notified body shall inform its designating authority approvals or recalls of quality systems, and shall, periodically or upon request, make the list of changes at the quality that is denied, suspended or otherwise restricted, accessible to its designating authority.

8.
Authorized Representative

Manufacturer obligations under Section 3.1., 3.5., 5 and 6 may, on his behalf and responsibility, are fulfilled by the manufacturer's authorized representative, if so specified in the authorization.

Module E1 - Quality assurance by inspection and testing of the final product

1.

"Quality assurance by inspection and testing of the final product" is the conformity assessment procedure whereby the manufacturer fulfills the obligations in point 2, 4 and 7, and ensures and declares on own responsibility that the affected measuring instruments are in accordance with the requirements of these regulations and the instrument-specific regulations.

2.
Technical documentation

The manufacturer shall establish the technical documentation described in § 4-12. The documentation shall make it possible to assess the measure tool is in accordance with the requirements of these regulations and the instrument-specific regulations, and shall include an adequate analysis and assessment of risk. It shall specify the relevant requirements, and to the extent it is relevant for such assessment, cover måleredskapets design, production and function.

3.
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for ten years after the measuring instrument has been made available on the market first.

4.
production

The manufacturer shall apply an approved quality control of the final product and testing of the affected measuring instrument as defined in paragraph 5, and is comprised of the follow-up paragraph 6.

5.
quality

5.1.
The manufacturer shall submit an application for assessment of the quality system relating to appropriate measuring instruments to a freely chosen Notified Body.

Application
shall contain the following:

A)
manufacturer's name and address and the representative's name and address if it has submitted your application,

B)
a written declaration that the same application has not been lodged with another notified body,

C)
all relevant information for the relevant instrument category,

D)
documentation for the quality system and

E)
the technical documentation referred to in point.

5.2.
The quality system must ensure that the measuring equipment is in compliance with the requirements of these regulations and the instrument-specific regulations.

All the elements, requirements and provisions adopted by the manufacturer into consideration shall be documented in a systematic and orderly manner in the form of quality policies, procedures and instructions. This quality system documentation must make it possible to interpret the quality programs, plans, manuals and records in a uniform manner.
It shall include in particular an adequate description of

A)
quality objectives and the organizational structure, responsibilities and powers with regard to product quality,

B)
techniques for manufacturing, quality control and quality assurance as well as processes and systematic measures used,

C)
records, such as inspection reports and test data, calibration data, qualification reports for relevant staff, etc.,

D)
measures for monitoring the planned product quality and the effective operation of the quality system.

5.3.
The notified body must assess the quality system to determine whether it satisfies the requirements referred to in Section 5.2.

It shall presume compliance with these requirements in respect of the elements of a quality system that complies with the corresponding specifications of the relevant harmonized standard.
In addition to experience in quality management systems, at least one member of the control team have experience with evaluation in the relevant instrument area and the current instrument technique, and have knowledge of the relevant requirements of these regulations and the instrument-specific regulations. The inspection shall include an inspection visit to the manufacturer's premises.
Control team will examine the technical documentation referred to in paragraph 2 to verify that the manufacturer fail to determine the relevant requirements of these regulations and the instrument-specific regulations, and conduct the investigations necessary to ensure that the measuring instrument is in compliance with these demands.
The result shall be communicated to the manufacturer. The notification must contain the conclusions of the examination and the reasoned assessment decision.

5.4.
The manufacturer undertakes to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

5.5.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the amended quality system still meets the requirements referred to in Section 5.2., Or whether a reassessment is required.
It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.

6.
The notified body responsible for supervising

6.1.

The purpose of monitoring is to ensure that the manufacturer duly fulfills the obligations arising out of the approved quality system.

6.2.
The manufacturer shall for control purposes allow the notified body access to inspect production, inspection, testing and storage conditions, and provide all necessary information, in particular;

A)
quality system documentation,

B)
the technical documentation referred to in paragraph 2

C)
quality records, such as inspection reports and test data, calibration data, qualification reports for relevant staff etc.

6.3.
The notified body shall carry out regular checks to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report against the manufacturer.

6.4.
Furthermore, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out or let carry out instrument tests to check that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and, if tests are performed, a test report.

7.
Conformity marking and EC Declaration

7.1.
The manufacturer shall affix the CE marking, the supplementary metrology marking referred to in this regulation, and, under the notified body referred to in paragraph 5.1. their responsibilities, the latter's identification number to each individual measuring instrument that meets the relevant requirements of these regulations and the instrument-specific regulations.

7.2.
The manufacturer prepares a written EU declaration of conformity for each type of instrument and store this at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first. It shall identify the instrument type it has been drawn.

A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
A copy of the EC declaration of conformity to accompany each measuring instrument that is made available on the market first. This requirement may be interpreted as applying to a party or a transmission rather than for the individual measuring instrument, in cases where a large number of measuring instruments are delivered to a single user.

8.
The manufacturer shall for ten years after the measuring instrument has been made available on the market the first time at the disposal of the national authorities;

A)
documentation referred to in Section 5.1.,

B)
information about approved amendments referred to in paragraph 5.5., And

C)
results and reports from the notified body referred to in Section 5.5., 6.3. and 6.4.

9.
Each notified body shall inform its designating authority approvals or recalls of quality systems, and shall, periodically or upon request, make the list of changes at the quality that is denied, suspended or otherwise restricted, accessible to its designating authority.

10.
Authorized Representative

Manufacturer obligations under paragraph 3, 5.1., 5.5., 7 and 8, on his behalf and responsibility, are fulfilled by the manufacturer's authorized representative, if so specified in the authorization.

Module F - Initial Verification

1.
"Initial Verification" is the part of a conformity assessment procedure whereby the manufacturer fulfills the obligations of section 2 5.1. and 6, and ensures and declares on own responsibility that the measuring tools that have been inspected in accordance with paragraph 3 are in conformity with the type described in the EC type examination certificate and satisfy the relevant requirements of these regulations and the instrument-specific regulations.

2.
production

The manufacturer shall take all measures necessary so that the manufacturing process and its follow-up ensures that the manufactured measuring equipment is in compliance with the approved type described in the EC type examination certificate and the requirements of these regulations and the instrument-specific regulations.

3.
control

A notified body chosen by the manufacturer shall carry out, or let perform appropriate examinations and tests to check the measuring instrument the conformity with the type described in the EC type examination certificate and the requirements of these regulations and the instrument-specific regulations.
Examinations and tests to verify compliance with metrological requirements is performed, chosen by the manufacturer, either by examination and testing of every measuring instrument as specified in paragraph 4, or, for measuring instruments that are not non-automatic weighing instruments, by examination and testing of measuring tools on a statistical basis as specified in paragraph 5.

4.
Initial Verification of conformity by examination and testing of each individual measuring instrument

4.1.

All measuring tools examined individually and performed relevant tests as specified in the relevant harmonized standards and / or normative documents and / or equivalent tests as specified in the relevant technical specifications to make sure they comply with the approved type described in EC type certification certificate and relevant requirements applicable to them. In the absence of a harmonized standard or a normative document shall be notified body concerned decide on the appropriate tests to be performed.

4.2.
The notified body shall issue a certificate of conformity on the basis of conducted surveys and tests, and shall affix its identification number to each approved measuring instrument or have it applied under their responsibility.

Manufacturer shall keep the certificates of conformity available for inspection by the national authorities for ten years after the measuring instrument was made available on the market first.

5.
Initial verification based on statistical verification

5.1.
The manufacturer shall take all necessary measures for the manufacturing process and ongoing monitoring to ensure that each manufactured batch is homogeneous, and shall submit its measuring instruments for control in the form of homogeneous lots.

5.2.
Of each batch taken a spare meters after the requirements of Section 5.3. All measuring instruments in spare meters are examined individually and appropriate tests as set out in the relevant harmonized standards and / or normative documents and / or equivalent tests laid down in other relevant technical specifications must be performed to determine if they comply the type described in the EC type examination certificate and with the requirements that apply to them in this regulation and the instrument-specific regulation, so that it can be determined whether the party should be approved or not approved. In the absence of such a harmonized standard or normative document shall be notified body concerned decide on the appropriate tests to be performed.

5.3.
The statistical procedure shall meet the following requirements:

The statistical verification shall be based on atributtmetoden. The sampling system shall ensure that

A)
if a party is less than 1% that do not meet the requirements, there should be minimum 95% probability of acceptance,

B)
if a party is less than 7% that do not meet the requirements, there should be a limit quality of 5% probability of acceptance.

5.4.
If the batch is accepted, approved all measuring instruments in the party except the measuring instruments of spare meters that were found not to pass the tests.

The notified body shall issue a certificate of conformity on the basis of the examinations and tests carried and affix its identification number to each approved measuring instrument or get this attached under their responsibility.
Manufacturer shall keep the certificates of conformity at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first.

5.5.
If a lot is rejected, the notified body shall take appropriate measures to prevent the party made available on the market. In case frequent disapprovals of batches the notified body may suspend the statistical check and take appropriate measures.

6.
Conformity marking and EC Declaration

6.1.
The manufacturer shall affix the CE marking, the supplementary metrology marking referred to in these Regulations, and under the notified body referred to in paragraph 3 responsibility, the latter's identification number to each individual measuring instrument that is in conformity with the approved type described in the EC type examination certificate and meet the requirements these regulations and the instrument-specific regulations.

6.2.
The manufacturer prepares a written EU declaration of conformity for each type of instrument and store this at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first. It shall identify the instrument type it has been drawn.

A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
A copy of the EC declaration of conformity to accompany each measuring instrument that is made available on the market first. This requirement may be interpreted as applying to a party or a transmission rather than for the individual measuring instrument in cases where a large number of measuring instruments are delivered to a single user. This is not required for non-automatic weighing instruments.
If the notified body referred to in paragraph 3 consent, and from the latter's responsibility, the manufacturer may also affix the notified body's identification number to the measuring tools.

7.

If the notified body agrees and under thereof responsibility, the manufacturer, affix the notified body's identification number to the measuring tools during the manufacturing process.

8.
Authorized Representative

Manufacturer obligations may, on his behalf and responsibility, are fulfilled by the manufacturer's authorized representative, if so specified in the authorization. The authorized representative may not fulfill the obligations referred to in paragraphs 2 and 5.1.

Module F1 - Conformity based on product verification

1.
"Conformity based on product verification 'is the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in paragraphs 2, 3, 6.1. and 7, and ensures and declares on own responsibility that the relevant measuring instruments of the provisions of paragraph 4, meets the requirements of these regulations and the instrument-specific regulations.

2.
Technical documentation

The manufacturer shall establish the technical documentation described in § 4-12. The documentation shall make it possible to assess the measure tool is in accordance with the requirements of these regulations and the instrument-specific regulations, and shall include an adequate analysis and assessment of risk. It shall specify the relevant requirements, and to the extent it is relevant for such assessment, måleredskapets design, production and function.
The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for ten years after the measuring instrument has been made available on the market first.

3.
production

The manufacturer shall take all measures necessary to ensure that the manufacturing process and its follow-up ensures that the manufactured measuring tools meet the requirements of these regulations and the instrument-specific regulations.

4.
control

A notified body chosen by the manufacturer shall carry out, or let perform appropriate examinations and tests, to check the measuring instrument the conformity with the requirements of these regulations and the instrument-specific regulations.
Examinations and tests to verify compliance with metrological requirements is performed, chosen by the manufacturer, either by examination and testing of every measuring instrument as defined in paragraph 5 or, for measuring instruments that are not non-automatic weighing instruments, by examination and testing of measuring tools on a statistical basis as specified in paragraph 6.

5.
Initial Verification of conformity by examination and testing of each individual measuring instrument

5.1.
All measuring instruments examined individually and performed relevant tests as specified in the relevant harmonized standards and / or normative documents and / or equivalent tests as indicated in other relevant technical specifications to make sure they comply with the relevant metrological requirements. In the absence of such a harmonized standard or normative document shall be notified body concerned decide on the appropriate tests to be performed.

5.2.
The notified body shall issue a certificate of conformity on the basis of the examinations and tests carried and affix its identification number to each approved measuring instrument or arrange to have it affixed.

Manufacturer shall keep the certificates of conformity at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first.

6.
Initial verification based on statistical verification

6.1.
The manufacturer shall take all necessary measures for the manufacturing process to ensure that each manufactured batch is homogeneous, and shall submit its measuring instruments for control in the form of homogeneous lots.

6.2.
Of each batch taken a spare meters after the requirements of Section 6.4.

6.3.
All measuring instruments in spare meters are examined individually and appropriate tests as set out in the relevant harmonized standards and / or normative documents, and / or similar tests in other relevant technical specifications, is performed to determine if they comply with the requirements applicable to them in these regulations and the instrument-specific regulations, and to determine whether the party should be approved or not approved. In the absence of such a harmonized standard or normative document shall be notified body concerned decide on the appropriate tests to be performed.

6.4.
The statistical procedure shall meet the following requirements:

The statistical verification shall be based on atributtmetoden. The sampling system shall ensure that

A)
if a party is less than 1% that do not meet the requirements, there should be minimum 95% probability of acceptance,

B)

If a party is less than 7% that do not meet the requirements, there should be a limit quality of 5% probability of acceptance.

6.5.
If the batch is accepted, approved all measuring instruments in the party except the measuring instruments of spare meters that were found not to pass the tests.

The notified body shall issue a certificate of conformity on the basis of the examinations and tests carried, and shall affix its identification number to each approved measuring instrument or arrange to have it affixed under its responsibility.
Manufacturer shall keep the certificates of conformity at the disposal of the national authorities for ten years after the measuring instrument was made available on the market first time
If a lot is rejected, the notified body shall take appropriate measures to prevent the party being made available on the market. In the event of frequent disapprovals of batches, the notified body may suspend the statistical check and take appropriate measures.

7.
Conformity marking and EC Declaration

7.1.
The manufacturer shall affix the CE marking, the supplementary metrology marking referred to in these Regulations, and under the notified body referred to in paragraph 4 its responsibility, affix the latter's identification number to each individual measuring instrument that complies with these regulations and the instrument-specific regulations.

7.2.
The manufacturer prepares a written EU declaration of conformity for each type of instrument and store this at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first. It shall identify the instrument type it has been drawn.

A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
A copy of the EC declaration of conformity to accompany each measuring instrument being made available on the market first. A copy of the declaration shall accompany each measuring instrument that is made available on the market first. This requirement may be interpreted as applying to a party or a transmission rather than for the individual measuring instrument, in cases where a large number of measuring instruments are delivered to a single user. This section does not apply to non-automatic weighing instruments.

8.
If the notified body agrees and under thereof responsibility, the manufacturer, affix the notified body's identification number to the measuring tools during the manufacturing process.

9.
Authorized Representative

Manufacturer obligations may, on his behalf and responsibility, are fulfilled by the manufacturer's authorized representative, if so specified in the authorization. The authorized representative may not fulfill the obligations referred to in paragraph 2, first paragraph, section 3 and section 6.1.

Module G - Conformity based on unit verification

1.
"Conformity based on unit verification 'is the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in paragraphs 2, 3 and 5, and ensures and declares on own responsibility that a measuring instrument covered by the provisions of paragraph 4, meets the requirements of these regulations and the instrument-specific Regulations.

2.
Technical documentation

The manufacturer shall establish the technical documentation described in § 4-12, and shall make it available to the notified body referred to in paragraph 4. The technical documentation shall make it possible to assess whether the measuring instrument complies with the requirements of these regulations and the instrument-specific regulations, and shall include an adequate analysis and assessment of risk. It shall specify the relevant requirements, and to the extent it is relevant for such assessment, cover måleredskapets design, production and function.
The manufacturer shall keep the technical documentation at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first.

3.
production

The manufacturer shall take all measures necessary so that the manufacturing process and monitoring of this ensures that the produced measuring instrument meets the requirements of these regulations and the instrument-specific regulations.

4.
control

A notified body chosen by the manufacturer shall carry out, or let perform the appropriate examinations and tests as specified in the relevant harmonized standards and / or normative documents, or equivalent tests as indicated in other relevant technical specifications to verify måleredskapets accordance with the requirements of these regulations and the instrument-specific regulations. In the absence of such a harmonized standard or normative document shall be notified body concerned decide on the appropriate tests to be performed.

The notified body shall issue a certificate of conformity on the basis of the examinations and tests carried, and affix its identification number to the approved measuring instrument or have it affixed under its responsibility.
The manufacturer shall keep the certificate of conformity at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first.

5.
Conformity marking and EC Declaration

5.1.
The manufacturer shall affix the CE marking, the supplementary metrology marking referred to in this regulation, and, under the notified body referred to in paragraph 4 responsibility, the latter's identification number to each measuring instrument that complies with these regulations and the instrument-specific regulations.

5.2.
The manufacturer shall draw up a written EU declaration of conformity and keep it at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first. EU declaration of conformity shall identify the measuring instrument has been prepared for.

A copy of the EC declaration of conformity shall be made available to the relevant authorities upon request.
A copy of the EC declaration of conformity to accompany measuring tool. This is not required for non-automatic weighing instruments.

6.
Authorized Representative

Manufacturer obligations under paragraphs 2 and 5 may, on his behalf and responsibility, are fulfilled by the manufacturer's authorized representative, if so specified in the authorization.

Module H - Conformity based on full quality assurance

1.
"Conformity based on full quality assurance" is the conformity assessment procedure whereby the manufacturer fulfills the obligations laid down in paragraphs 2 and 5, and ensures and declares on own responsibility that the affected measuring instruments meet the requirements of these regulations and the instrument-specific regulations.

2.
production

The manufacturer shall apply an approved quality system for design, production and inspection and testing of the affected measurement tools as specified in section 3, and is covered by follow-up paragraph 4.

3.
quality

3.1.
The manufacturer shall submit an application for assessment of his quality system with a freely chosen Notified Body, for the affected measuring instruments.

The application shall include the following:

A)
manufacturer's name and address. If the application is submitted by an authorized representative, the name and address of this also be included,

B)
technical documentation, as described in § 4-12, for a model for each category measuring instrument to be produced. The documentation shall make it possible to assess the measure tool complies with the relevant requirements, and shall include an adequate analysis and assessment of risk. The technical documentation shall specify the applicable requirements and design, manufacture and use of measuring instrument to the extent it is relevant for the assessment,

C)
documentation regarding the quality system and

D)
written declaration that the same application has not been submitted to other notified body.

3.2.
The quality system must ensure that the measuring equipment is in compliance with the requirements of these regulations and the instrument-specific regulations.

All the elements, requirements and provisions adopted by the manufacturer into consideration shall be documented in a systematic and orderly manner in the form of quality policies, procedures and instructions. This quality system documentation must make it possible to interpret quality plans, plans, manuals and records in a uniform manner. It must include in particular a complete description of

A)
quality objectives and the organizational structure, responsibilities and powers with regard to design and product quality,

B)
technical design specifications, including standards, that will be applied and, where the relevant harmonized standards and / or normative documents will not be used in full, how it is ensured that the requirements in the instrument-specific regulations will be fulfilled by using other relevant technical specifications

C)
techniques for design control and design assurance and processes and systematic measures used when designing the measuring instruments in connection with the relevant instrument category,

D)
similar techniques for manufacturing, quality control and quality assurance as well as processes and systematic measures used,

E)
examinations and tests to be carried out before, during and after manufacture, and the frequency they performed with

F)
records, such as inspection reports and test data, calibration data, qualification reports for relevant staff, and

G)
measures for monitoring the necessary construction quality and product quality, and efficient operation of the quality system.

3.3.

The notified body must assess the quality system to determine whether it meets the requirements specified in section 3.2. It shall presume compliance with the requirements applicable elements of the quality system that complies with the corresponding specifications of the relevant harmonized standard.

In addition to experience in quality management systems, at least one member of the control team have experience with evaluation in the relevant instrument area and the current instrument technology, and knowledge of the requirements of these regulations and the instrument-specific regulations. The inspection shall include an inspection visit to the manufacturer's premises.
To ensure that the manufacturer fail to determine the relevant requirements of these regulations and the instrument-specific regulations, and carry out the necessary investigations to ensure that the measuring instrument meets these requirements, the inspection team will evaluate the technical documentation referred to in Section 3.1. letter b.
The result shall be communicated to the manufacturer or his authorized representative. The notification must contain the conclusions of the inspection and a reasoned assessment decision.

3.4.
The manufacturer undertakes to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.
The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the amended quality system will still satisfy the requirements referred to in paragraph 3.2. Or whether a reassessment is required.
It must notify the manufacturer of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.

4.
The notified body responsible for supervising

4.1.
The purpose of monitoring is to ensure that the manufacturer duly fulfills the obligations arising out of the approved quality system.

4.2.
Considering control, the manufacturer must allow the notified body access to the areas of design, manufacture, inspection, testing and storage and provide all necessary information, especially

A)
quality system documentation,

B)
quality records as provided for structural part of the quality system, such as results of analyzes, calculations, tests, and

C)
quality records as provided for manufacturing part of the quality system, such as inspection reports and test data, calibration data and qualification reports for relevant staff.

4.3.
The notified body shall carry out regular checks to ensure that the manufacturer maintains and applies the quality system and shall submit an audit report against the manufacturer.

4.4.
Furthermore, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out or let carry out instrument tests to check that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and a test report if tests are performed.

5.
Conformity marking and EC Declaration

5.1.
The manufacturer shall affix the CE marking, the supplementary metrology marking referred to in this regulation, and, by the notified body referred to in paragraph 3.1. their responsibilities, the latter's identification number to each individual measuring instrument that complies with these regulations and the instrument-specific regulations.

5.2.
The manufacturer shall draw up a written EU declaration of conformity for each instrument type and keep it at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first. EU declaration of conformity shall identify the instrument type it has been drawn.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.
A copy of the EC declaration of conformity to accompany each measuring instrument that is made available on the market first. This requirement may be interpreted as applying to a party or a transmission rather than for the individual measuring instrument in cases where a large number of measuring instruments are delivered to a single user.

6.
The manufacturer shall for ten years after the measuring instrument was made available on the market the first time, keep at the disposal of the national authorities;

A)
the technical documentation referred to in Section 3.1.,

B)
documentation concerning the quality system referred to in Section 3.1.,

C)
information regarding changes referred to in Section 3.5., As approved

D)
results and reports from the notified body referred to in Section 3.5., 4.3. and 4.4.

7.

Each notified body shall inform its designating authority if adopted approvals or recalls of quality system, and shall, periodically or upon request, make a list of quality system approvals granted, refused or withdrawn, provided for its designating authority.

8.
Authorized Representative

Manufacturer obligations under Section 3.1., 3.5., 5 and 6 may, on his behalf and responsibility, are fulfilled by the manufacturer's authorized representative, if so specified in the authorization.

Module H1 - Conformity based on full quality assurance and design examination

1.
"Conformity based on full quality assurance and design examination" is the conformity assessment procedure whereby the manufacturer fulfills the obligations in paragraphs 2 and 6, and ensures and declares on own responsibility that the affected measuring instruments meet the requirements of these regulations and the instrument-specific regulations.

2.
production

The manufacturer shall apply an approved quality system for design, production and inspection and testing of the affected measuring instrument as defined in Section 3, and is subject to supervision paragraph 5.
There accordance with the procedure in paragraph 4 have been investigated that måleredskapets technical construction is suitable.

3.
quality

3.1.
The manufacturer shall submit an application for assessment of his quality system with a freely chosen Notified Body, for the affected measuring instruments.

The application shall include the following:

A)
manufacturer's name and address. If the application is submitted by an authorized representative, the name and address of this also be included,

B)
all relevant information for the desired instrument category,

C)
documentation regarding the quality system and

D)
written declaration that the same application has not been submitted to other notified body.

3.2.
The quality system must ensure that the measuring equipment is in compliance with the requirements of these regulations and the instrument-specific regulations.

All the elements, requirements and provisions adopted by the manufacturer into consideration shall be documented in a systematic and orderly manner in the form of quality policies, procedures and instructions. This quality system documentation must make it possible to interpret quality plans, plans, manuals and records in a uniform manner.
Particular, it shall contain a full description of

A)
quality objectives and the organizational structure, responsibilities and powers with regard to design and product quality,

B)
technical design specifications, including standards, that will be used, and, if the relevant harmonized standards and / or normative documents are not used in full, how it is ensured that the requirements of these regulations and the instrument-specific regulations applicable to measurement tools, will be met by using other relevant technical specifications

C)
techniques for design control and design assurance and processes and systematic measures used when designing the measuring instruments in connection with the relevant instrument category,

D)
similar techniques for manufacturing, quality control and quality assurance as well as processes and systematic measures used,

E)
examinations and tests to be carried out before, during and after manufacture, and the frequency they performed with

F)
records, such as inspection reports and test data, calibration data, qualification reports for relevant staff, and

G)
measures for monitoring the necessary construction quality and product quality and the effective operation of the quality system.

3.3.
The notified body must assess the quality system to determine whether it meets the requirements specified in section 3.2. It shall presume compliance with the requirements applicable elements of the quality system that complies with the corresponding specifications of the relevant harmonized standard.

In addition to experience in quality management systems, at least one member of the control team have experience with evaluation in the relevant instrument area and the current instrument technology, and knowledge of the requirements of these regulations and the instrument-specific regulations. Control to the Notified Body shall include an inspection visit to the manufacturer's premises.
The result shall be communicated to the manufacturer or his authorized representative. The notification must contain the conclusions of the inspection and a reasoned assessment decision.

3.4.
The manufacturer undertakes to fulfill the obligations arising from the quality system as approved and to maintain it so that it remains adequate and efficient.

3.5.

The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

The notified body shall evaluate any proposed changes and decide whether the amended quality system will still meet the requirements specified in section 3.2. Or whether a reassessment is required.
It must notify the manufacturer or his authorized representative of its decision. The notification must contain the conclusions of the examination and the reasoned assessment decision.

3.6.
Each notified body shall inform its designating authority if adopted approvals or recalls of quality system, and shall, periodically or upon request, be able to obtain for its designating authority the list of quality system approvals granted, refused or withdrawn.

4.
Construction Survey

4.1.
The manufacturer shall submit an application for examination of the design with the notified body referred to in paragraph 3.1.

4.2.
The application shall enable understanding måleredskapets design, production of it and its function, and should make it possible to assess conformity with the requirements of these regulations and the instrument-specific regulations. The application shall include

A)
manufacturer's name and address,

B)
a written declaration that the same application has not been lodged with another notified body,

C)
the technical documentation described in § 4-12. The documentation shall make it possible to assess the measure tool is in accordance with the requirements of these regulations and the instrument-specific regulations, and shall include an adequate analysis and assessment of risk. It shall, to the extent it is relevant for such assessment, cover måleredskapets structure and function, and

D)
supporting documentation for the technical structure suitability. This additional documentation shall mention any documents that are used, in particular where the relevant harmonized standards and / or normative documents are not used in full and shall, if appropriate, include the results of tests carried out in accordance with other relevant technical specifications, the manufacturer's suitable laboratory, or by another testing laboratory on behalf of the manufacturer or the manufacturer's responsibility.

4.3.
The notified body shall consider the application and if the construction complies with the provisions of these regulations and the instrument-specific regulations that apply to the measuring instrument it shall issue an EC certificate design examination of the manufacturer. The certificate must contain the name and address, the conclusions of the examination, any conditions for its validity and the necessary data for identification of the approved design. The certificate may contain one or more attachments.

EU examination certificate and its annexes shall contain all relevant information that makes it possible to assess whether the produced measuring instrument with the assessed design meets the requirements for compliance, and make it possible to control the measuring instrument during use. It should make it possible to assess whether they produced measuring equipment is in accordance with the estimated construction with respect to reproducibility of the metrological performance capability when properly regulated, including

A)
instrumentkonstruksjonens metrological characteristics,

B)
measures required to ensure that the measuring instrument is intact (sealing, identification of software, etc..)

C)
information on other elements necessary to identify the measuring instrument and to check that måleredskapets outer corresponded construction,

D)
any specific information necessary to verify produced måleredskapers properties

E)
for a sub-unit, all information necessary to ensure compatibility with other sub-assemblies or measuring instruments.

The notified body shall establish an evaluation report in this regard and set it at the disposal of its designating authority. Subject to § 4-28 the agency shall fully or partially only make public the contents of this report with the manufacturer's consent.
The certificate shall have a validity of ten years from the date of issue and can be renewed for successive ten-year periods.
The notified body shall issue an EC certificate design examination if the design does not satisfy the requirements of these regulations and the instrument-specific regulations. The notified body shall then inform the applicant accordingly, giving detailed reasons for its refusal.

4.4.

The notified body shall keep itself informed of any changes in the generally recognized technological condition, indicating that the approved design no longer meets the requirements for compliance of these regulations and the instrument-specific regulations, and shall determine whether such changes require further investigation. Authority shall then inform the manufacturer thereof.

The manufacturer shall keep the notified body that issued the EU-examination certificate, informed of any changes to the approved design that may affect compliance with the requirements of these regulations and the instrument-specific regulations or the conditions of validity. Such amendments must receive additional approval from the notified body which issued the EU-examination certificate, in the form of an addition to the original EU-examination certificate.

4.5.
Each notified body shall inform its designating authority for EU certificates for design review and / or amendments thereof, which it has issued or withdrawn. The notified body shall, periodically or upon request, make the list of certificates and / or any amendments thereto, which is denied, suspended or otherwise restricted, accessible to its designating authority.

European Commission, Member States and the other notified bodies may on request obtain a copy of the EU-examination certificate and / or amendments thereto. The European Commission and Member States on request obtain a copy of the technical documentation and the results of surveys conducted by the notified body.
The notified body shall keep a copy of the EU-examination certificate as well as additions and amendments thereto, in addition to the technical documentation from the manufacturer, until the expiry of its validity period.

4.6.
The manufacturer shall keep a copy of the EC examination certificate, its annexes and additions together with the technical documentation for ten years after the measuring instrument was made available on the market the first time at the disposal of the national authorities.

5.
The notified body responsible for supervising

5.1.
The purpose of monitoring is to ensure that the manufacturer duly fulfills the obligations arising out of the approved quality system.

5.2.
In order to implement control, the manufacturer shall provide the notified body access to inspect areas of design, manufacture, inspection, testing and storage and provide all necessary information, in particular:

A)
quality system documentation,

B)
quality records as foreseen by the design part of the quality system, such as results of analyzes, calculations, tests, etc., And

C)
quality records as foreseen by manufacturing part of the quality system, such as inspection reports and test data, calibration data, qualification reports for relevant staff etc.

5.3.
The notified body shall carry out regular checks to ensure that the manufacturer maintains and applies the quality system and shall provide an audit report against the manufacturer.

5.4.
Furthermore, the notified body may pay unannounced visits to the manufacturer. During such visits the notified body may carry out or let carry out instrument tests to check that the quality system is functioning correctly. It shall provide the manufacturer with a visit report and a test report if tests are performed.

6.
Conformity marking and EC Declaration

6.1.
The manufacturer shall affix the CE marking and the supplementary metrology marking referred to in this regulation, and, under the notified body as mentioned in Section 3.1. their responsibilities, the latter's identification number to each individual measuring instrument that complies with these regulations and the instrument-specific regulations.

6.2.
The manufacturer shall draw up a written EU declaration of conformity for each instrument type and keep it at the disposal of the national authorities for ten years after the measuring instrument has been made available on the market first. EU declaration of conformity shall identify the instrument type it is prepared for, and specify the number of EU-examination certificate.

A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

A copy of the EC declaration of conformity to accompany each measuring instrument that is made available on the market first. This requirement may be interpreted as applying to a party or a transmission rather than for the individual measuring instrument in cases where a large number of measuring instruments are delivered to a single user.

7.
The manufacturer shall for ten years after the measuring instrument was made available on the market the first time, keep at the disposal of the national authorities

A)
documentation quality system referred to in Section 3.1.,

B)
information about approved changes mentioned in section 3.5., And

C)
results and reports from the notified body referred to in Section 3.5., 5.3. and 5.4.

8.
Authorized Representative

Manufacturer's authorized representative may submit the application referred to in paragraph 4.1. and 4.2., and fulfilling obligations under Section 3.1., 3.5., 4.4., 4.6., 6 and 7, on his behalf and responsibility, if so specified in the authorization.

Appendix no. 2 to Regulations on measurement units and measurement, cf. Regulations § 4-11.

EU DECLARATION (Nr. XXXX) 1

1.
Måleredskapets model / measuring instrument (product, type, batch or serial number).

2.
The manufacturer's name and address and possibly its authorized representative.

3.
This declaration of conformity is issued under the responsibility of the manufacturer.

4.
Declaration object (identification of measurement tool that makes it possible to trace it, may occasionally include a picture to identify the measuring instrument).

5.
Declaration object described above is in accordance with relevant provisions of Union harmonization legislation.

6.
References to the relevant harmonized standards or normative documents have been applied, or reference to the other technical specifications declaring compliance.

7.
Where applicable, the notified body ... (name, number) performed ... (description of intervention) and issued the certificate.

8.
Additional information:

Signed for and on behalf of:
(place and date of issue)
(name, position) (signature)